RULESGrants and Cooperative Agreements to State and Local Governments:Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals and Other Non-Profit Organizations, 61597-615992011-25416TreasuryTreasury DepartmentSee

We are adopting a new airworthiness directive (AD) for all Airbus Model A300 series airplanes; Model A310 series airplanes; and Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model C4-605R Variant F airplanes (collectively called A300-600 series airplanes). This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

A recent analysis conducted by the manufacturer showed a particular risk for explosive failure of the * * * hydraulic accumulator.

This condition, if not detected and corrected, might, for some aeroplane installations, lead to damage to all three hydraulic circuits, possibly resulting in loss of control of the aeroplane or could, for certain other aeroplane installations, lead to an undetected fire in the wheel bay.

We are issuing this AD to require actions to correct the unsafe condition on these products.

DATES:

This AD becomes effective November 9, 2011.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of November 9, 2011.

ADDRESSES:

You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on June 22, 2011 (76 FR 36387). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

Since 1984, the design of the hydraulic accumulator installed on all the affected Airbus types has changed. The Part Number (P/N) remained the same, but the manufacturer did not record the serial number of the part that was the first to be manufactured to the changed design specification.

The new design hydraulic accumulator is manufactured with 2 pieces unit welded, instead of 4 pieces unit with 3 welds (old design) as pictured in Appendix 1 of this [EASA] AD. The welding process of the new design hydraulic accumulator provides a higher strength shell material and more reliability.

A recent analysis conducted by the manufacturer showed a particular risk for explosive failure of the old design hydraulic accumulator.

This condition, if not detected and corrected, might, for some aeroplane installations, lead to damage to all three hydraulic circuits, possibly resulting in loss of control of the aeroplane or could, for certain other aeroplane installations, lead to an undetected fire in the wheel bay.

For the reasons explained above, this [EASA] AD requires a one time detailed visual inspection to identify the old designed accumulators installed on certain hydraulic systems, the replacement of those accumulators by new designed accumulators and, irrespective of findings, the installation of warning placards to avoid installation of old designed accumulators on the affected hydraulic systems.

You may obtain further information by examining the MCAI in the AD docket.

Comments

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (76 FR 36387, June 22, 2011) or on the determination of the cost to the public.

Conclusion

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

Costs of Compliance

We estimate that this AD will affect about 184 products of U.S. registry. We also estimate that it will take about 7 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $197 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $145,728, or $792 per product.

In addition, we estimate that any necessary follow-on actions would take about 5 work-hours and require parts costing $10,700, for a cost of $11,125 per product. We have no way of determining the number of products that may need these actions.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator.“Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

1. Is not a ”significant regulatory action” under Executive Order 12866;

2. Is not a ”significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 36387, June 22, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

A recent analysis conducted by the manufacturer showed a particular risk for explosive failure of the * * * hydraulic accumulator.

This condition, if not detected and corrected, might, for some aeroplane installations, lead to damage to all three hydraulic circuits, possibly resulting in loss of control of the aeroplane or could, for certain other aeroplane installations, lead to an undetected fire in the wheel bay.

Compliance

(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.

Inspection, Replacement, and Placard Installation

(g) Within 30 months or 6,000 flight hours after the effective date of this AD, whichever occurs first: Do a detailed inspection of each type 5 hydraulic accumulator, part number (P/N) 3059103-1, P/N 3059103-2, P/N 3059103-8, and P/N 3059103-9, to determine if an old design accumulator (i.e., pre-1984) is installed on any affected hydraulic circuit indicated in table 1 of this AD, as applicable, in accordance with the Accomplishment Instructions of the applicable Airbus mandatory service bulletin identified in table 2 of this AD.

(h) If, during any detailed inspection required by paragraph (g) of this AD, an old design hydraulic accumulator (i.e., pre-1984) is found installed on any affected hydraulic circuit as indicated in table 1 of this AD, as applicable to airplane model, before further flight replace each affected old design accumulator with a new design accumulator, in accordance with the Accomplishment Instructions of the applicable Airbus mandatory service bulletin identified in table 2 of this AD.

(i) Before further flight after accomplishing the inspection required by paragraph (g) of this AD: Install a placard at the designated location of any affected hydraulic circuit indicated in table 1 of this AD, as applicable to airplane model, in accordance with the Accomplishment Instructions of the applicable Airbus mandatory service bulletin identified in table 3 of this AD.

Note 1: This AD differs from the MCAI and/or service information as follows: No differences.

Other FAA AD Provisions

(j) The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to Attn: Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425) 227-2125; fax (425) 227-1149. Information may be e-mailed to: 9-ANM-116-AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

(2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

Related Information

(k) Refer to MCAI European Aviation Safety Agency (EASA) Airworthiness Directive 2011-0006, dated January 17, 2011; and the Airbus mandatory service bulletins identified in table 4 of this AD; for related information.

(l) You must use the following service information to do the actions required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approved the incorporation by reference (IBR) under 5 U.S.C. 552(a) and 1 CFR part 51 of the following service information on the date specified:

(8) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information on the availability of this material at the FAA, call 425-227-1221.

(9) You may also review copies of the service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

Reports have been received from a small number of HS.748 operators of finding cracks in the propeller hub port buttress threads of R212 and R251 propellers. The affected hubs had accumulated in excess of 6,000 flight hours. This condition, if not detected and corrected, could lead to propeller blade separation, possibly resulting in damage to the aeroplane and/or injury to persons on the ground.

We are issuing this AD to prevent propeller hub failure due to cracks in the hub, which could result in damage to the airplane.DATES:

This AD becomes effective November 9, 2011. The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of November 9, 2011.

ADDRESSES:

The Docket Operations office is located at Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on May 11, 2011 (76 FR 27281). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states that:

Reports have been received from a small number of HS.748 operators of finding cracks in the propeller hub port buttress threads of R212 and R251 propellers. The affected hubs had accumulated in excess of 6,000 flight hours. This condition, if not detected and corrected, could lead to propeller blade separation, possibly resulting in damage to the aeroplane and/or injury to persons on the ground.

The cracks originating from the root of the buttress threads in the blade ports are caused by high-cycle fatigue.

Comments

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM published in the Federal Register on May 11, 2011 (76 FR 27281) or on the determination of the cost to the public.

Since we published the NPRM in the Federal Register on May 11, 2011 (76 FR 27281), we changed the AD Docket No. from FAA-2011-0033, to FAA-2011-0735. The original number was inadvertently used both by the FAA Engine & Propeller Directorate, and the FAA Transport Airplane Directorate.

Also since we published the NPRM in the Federal Register on May 11, 2011 (76 FR 27281), we became aware that Dowty Propellers made minor changes to Alert Service Bulletin (ASB) No. 61-1043, Revision 6, and issued Revision 7, dated March 1, 2011. Revision 6 of the ASB had an incorrect Non-Destructive Testing (NDT) reference in Effectivity paragraph 1.D. We do not reference that paragraph in this AD, however, we changed the AD to reference the most current ASB, which is Revision 7.

Conclusion

We reviewed the available data and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

Costs of Compliance

Based on the service information, we estimate that this AD will affect about 2 propellers installed on one airplane of U.S. registry. We also estimate that it will take about 1 work-hour per propeller to comply with this AD. The average labor rate is $85 per work-hour. Required parts will cost about $20,000 per propeller. Based on these figures, we estimate the cost of the AD on U.S. operators to be $40,170.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (phone: (800) 647-5527) is provided in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

(d) This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. We are issuing this AD to prevent propeller hub failure due to cracks in the hub, which could result in damage to the airplane.

Actions and Compliance

(e) Unless already done, do the following:

(1) Within 500 flight hours after the effective date of this AD, and thereafter at intervals not exceeding 500 flight hours, inspect the buttress threads in the propeller hub and driving center assembly for cracks.

(m) You may review copies at the FAA, New England Region, 12 New England Executive Park, Burlington, MA; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD was prompted by four reports of unrecoverable engine stalls, during hover in a left-roll attitude. This AD requires the installation of an accessory gearbox (AGB) axis-A oil slinger nut to the axis-A shaft assembly. We are issuing this AD to prevent an unrecoverable engine stall, leading to a helicopter forced landing or accident.

DATES:

This AD is effective November 9, 2011.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of November 9, 2011.

ADDRESSES:

For service information identified in this AD, contact GE-Aviation, M/D Rm. 285, One Neumann Way, Cincinnati, OH 45215; phone: 513-552-3272; e-mail: geaeaoc@ge.com. You may review copies of the referenced service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.

We received four reports of GE CT7-8 series turboshaft helicopter engines experiencing unrecoverable engine stalls, during hover in a left-roll attitude. Investigation revealed that during a prolonged left roll, excessive return oil from the AGB may return to the A-sump and exceed the sump's scavenging capability. The sump then floods, leading to over-heated oil, which preheats the air entering the engine's compressor. This preheated air causes inlet thermal distortion. This condition, if not corrected, could result in an unrecoverable engine stall, leading to a helicopter forced landing or accident. We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in the Federal Register on May 2, 2011 (76 FR 24407). That NPRM proposed to require the installation of an AGB axis-A oil slinger nut to the axis-A shaft assembly.

Comments

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM published in the Federal Register on May 2, 2011 (76 FR 24407).

Since we issued the NPRM published in the Federal Register on May 2, 2011 (76 FR 24407), GE issued a revision to the service bulletin we are incorporating by reference in this AD. The revision includes new information in the procedure required to torque the oil slinger nut. This AD incorporates by reference, GE Aircraft Engines CT7-8 Turboshaft Engine Service Bulletin No. CT7-8 S/B 72-0033, Revision 1, dated April 28, 2011.

Also since we issued the NPRM published in the Federal Register on May 2, 2011 (76 FR 24407), we discovered that in the applicability paragraph, we inadvertently omitted engine serial number 953071. We corrected that omission in paragraph (c) (4) by changing “CT7-8E, engine S/Ns 953068 and below, and S/Ns 953070 and 953072” to “CT7-8E, engine S/Ns 953068 and below, and S/Ns 953070 through 953072”.

Conclusion

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes are consistent with the intent that was proposed in the NPRM published in the Federal Register on May 2, 2011 (76 FR 24407) for correcting the unsafe condition.

Costs of Compliance

We estimate that this AD will affect 80 engines installed on helicopters of U.S. registry. We also estimate that it will take about one work-hour per engine to perform the actions required by this AD, and that the average labor rate is $85 per work-hour. Required parts will cost about $700 per engine. Based on these figures, we estimate the total cost of the AD to U.S. operators to be $62,800.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, part A, subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

(d) This AD was prompted by four reports of unrecoverable engine stalls, during hover in a left-roll attitude. We are issuing this AD to prevent an unrecoverable engine stall, leading to a helicopter forced landing or accident.

Compliance

(e) Comply with this AD at the next engine shop visit, the next 1,500-hour helicopter inspection, or before operation after next engine installation, whichever occurs first.

(j) You must use the following service information to do the actions required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approved the incorporation by reference (IBR) under 5 U.S.C. 552(a) and 1 CFR part 51 of the following service information on the date specified:

(3) You may review copies of the service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

(4) You may also review copies of the service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at an NARA facility, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD requires inspecting to determine the clearance and any wire bundle damage between wire bundle W443 and the left forward rudder quadrant, followed by adjusting the minimum clearance between the wire bundle and the left forward rudder quadrant, and repairing any wire bundle damage. This AD was prompted by reports of contact between wire bundle W443 and the left forward rudder quadrant. We are issuing this AD to detect and correct contact between the wire bundle and the left forward rudder quadrant. Damage to the wire bundle from contact between the wire bundle and the left forward rudder quadrant could result in uncommanded stabilizer trim and autopilot disconnects due to shorted wires, potentially affecting the capability of the flightcrew during high work load and consequently reducing control of the airplane. Restricted movement of the rudder quadrant at full right rudder travel would reduce controllability of the airplane.

DATES:

This AD is effective November 9, 2011.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of November 9, 2011.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to the specified products. That NPRM was published in the Federal Register on January 18, 2011 (76 FR 2840). That NPRM proposed to require inspecting to determine the clearance and any wire bundle damage between wire bundle W443 and the left forward rudder quadrant, followed by adjusting the minimum clearance between the wire bundle and the left forward rudder quadrant, and repairing any wire bundle damage.

Comments

We gave the public the opportunity to participate in developing this AD. We have considered the comments received. The following presents the comments received on the proposal and the FAA's response to each comment.

Support for the NPRM

American Airlines, Delta Air Lines, and Continental Airlines (CAL) support the NPRM (76 FR 2840, January 18, 2011), and stated that they have been inspecting the affected airplanes in accordance with the original issue and revision 1 of the service information cited in the NPRM.

Request for Boeing To Add Instructions for Continued Airworthiness (ICAs)

CAL requested that the FAA ask Boeing to add the appropriate ICAs to the Boeing 737NG Aircraft Maintenance Manual (AMM), because CAL is concerned about inadvertently undoing the corrective actions proposed in the NPRM (76 FR 2840, January 18, 2011) during future maintenance.

We disagree with the request to ask Boeing for ICAs. Current maintenance procedures and inspections ensure that the unsafe condition corrected in accordance with the AD will not be undone during future maintenance. A maintenance task exists to do a general visual inspection (GVI) of the area above the outboard nose wheel well, an inspection derived from the enhanced zonal analysis procedure (EZAP). This GVI of the area includes inspecting the wire bundles for damage and ensures no interference (riding) condition exists. Also, the rudder travel test provided in the AMM already includes steps to verify that wire bundle W443 has a minimum clearance of 0.5 inch from the left forward rudder quadrant at full travel motion while someone operates the rudder pedals, which captures the intent of this AD action. Boeing has updated the 737NG AMM to Revision 45, dated June 15, 2011, to include minimum clearance of 0.5 inch for the rudder travel test. We have not changed the AD in this regard.

Conclusion

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD as proposed.

Costs of Compliance

We estimate that this AD will affect 870 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this AD.

Number of U.S.-registered airplanesFleet costInspection2$85$170870$147,900Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

(c) This AD applies to The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes, certificated in any category, as identified in Boeing Special Attention Service Bulletin 737-27-1282, Revision 1, dated June 14, 2010.

(e) This AD was prompted by reports of contact between wire bundle W443 and the left forward rudder quadrant. We are issuing this AD to detect and correct contact between the wire bundle and the left forward rudder quadrant. Damage to the wire bundle from contact between the wire bundle and the left forward rudder quadrant could result in uncommanded stabilizer trim and autopilot disconnects due to shorted wires, potentially affecting the capability of the flightcrew during high work load and consequently reducing control of the airplane. Restricted movement of the rudder quadrant at full right rudder travel would reduce controllability of the airplane.

Compliance

(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.

Wire Bundle W443 Inspection and Clearance Measurement

(g) Within 60 months after the effective date of this AD: Do a detailed inspection of wire bundle W443 for damage and measure for sufficient clearance, in accordance with Part 1 of the Work Instructions of Boeing Special Attention Service Bulletin 737-27-1282, Revision 1, dated June 14, 2010. If the wire bundle is undamaged, and sufficient clearance exists, no further action is required by this AD.

Wire Bundle W443 Undamaged: Clearance Adjustment

(h) If the clearance of wire bundle W443 in the inspection required by paragraph (g) of this AD is found to be insufficient, before further flight, adjust the wire bundle clearance, in accordance with Part 2 of the Work Instructions of Boeing Special Attention Service Bulletin 737-27-1282, Revision 1, dated June 14, 2010.

Wire Bundle W443 Damaged: Repair, and Clearance Adjustment

(i) If wire bundle W443 is found to be damaged in the inspection required by paragraph (g) of this AD, before further flight, repair the damaged wire bundle and adjust the wire bundle clearance, in accordance with Part 3 of the Work Instructions of Boeing Special Attention Service Bulletin 737-27-1282, Revision 1, dated June 14, 2010.

Credit for Actions Accomplished in Accordance With Previous Service Information

(j) Actions accomplished before the effective date of this AD in accordance with Boeing Special Attention Service Bulletin 737-27-1282, dated March 15, 2007, are considered acceptable for compliance with the corresponding action specified in this AD.

Alternative Methods of Compliance (AMOCs)

(k)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in the Related Information section of this AD. Information may be e-mailed to: 9-ANM-Seattle-ACO-AMOC-Requests@faa.gov.

(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

(m) You must use Boeing Special Attention Service Bulletin 737-27-1282, Revision 1, dated June 14, 2010, to do the actions required by this AD, unless the AD specifies otherwise.

(1) The Director of the Federal Register approved the incorporation by reference of Boeing Special Attention Service Bulletin 737-27-1282, Revision 1, dated June 14, 2010, under 5 U.S.C. 552(a) and 1 CFR part 51.

(3) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information on the availability of this material at the FAA, call 425-227-1221.

(4) You may also review copies of the service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at an NARA facility, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

DEA is amending its regulations to clarify the registration status of a registrant who voluntarily surrenders a Certificate of Registration. These changes clarify that a voluntary surrender of a registration signed by a registrant using any format has the legal effect of immediately terminating the registrant's registration without any further action by DEA.

Under current regulations, the DEA registration of any person terminates “if and when such person dies, ceases legal existence, or discontinues business or professional practice * * *.” 21 CFR 1301.52(a) and 1309.62(a). Under these provisions, no further action by DEA is needed to terminate a DEA Certificate of Registration after one of the specified events occurs. However, these regulations are silent about whether the automatic termination provisions apply upon a registrant's voluntary surrender of a DEA registration. Moreover, DEA Forms 104 (for controlled substance registrations) and 104c (for listed chemical registrations), which may be used by registrants to effectuate voluntary surrenders, state that submission of the forms “shall be authority for the Administrator of the Drug Enforcement Administration to terminate * * * my registration without an order to show cause, a hearing, or any other proceedings * * *.” Thus, the forms have led some registrants to believe that DEA must issue a final order revoking the registration after submission of the forms in order to terminate a DEA registration.

DEA regulations, however, do not require further action by DEA's Administrator to terminate a DEA registration after submission of a voluntary surrender and, in practice, DEA treats the submission of a voluntary surrender as an immediate termination of the DEA registration at issue. The only additional action taken by DEA in such cases is the entry of the surrender into DEA's registration database. Further, DEA regulations do not require a registrant to use any particular format to submit a voluntary surrender. DEA accepts voluntary surrenders as long as the registrant submits a signed statement expressing the desire to surrender a registration.

DEA Forms 104 and 104c are internal DEA documents that are available for registrant use. These forms will be revised consistent with this final rule to clarify that a signed voluntary surrender of a registration has the legal effect of immediately terminating the registrant's registration upon delivery of such statement to any DEA employee. No further action by DEA is required.

Notice of Proposed Rulemaking and Comments Received

To address the circumstances described above, DEA published a NPRM proposing the amendment of its regulations to clarify that a DEA registration terminates when DEA, through any employee, receives notice of a voluntary surrender of a DEA registration. 75 FR 32140, June 7, 2010. DEA did not receive any comments regarding the NPRM and is thus finalizing the rule as proposed.

Action Taken by This Rule

To ensure that there is no confusion as to actions necessary to effectuate the voluntary surrender of a DEA registration, DEA is revising the relevant regulations to state that a DEA registration terminates when DEA, through any employee, receives notice of a voluntary surrender of a DEA registration. Any format may be used as long as the registrant submits a signed statement expressing the desire to surrender a registration.

Regulatory AnalysesExecutive Orders 12866 and 13563

This regulation has been developed in accordance with the principles of Executive Orders 12866 and 13563. It has been determined that this is not a “significant regulatory action” that requires review by the Office of Management and Budget.

Regulatory Flexibility Act

The Deputy Assistant Administrator, Office of Diversion Control, has reviewed this regulation and hereby certifies that it has been drafted in accordance with the provisions of the Regulatory Flexibility Act (5 U.S.C. 601-612), and by approving it certifies that this regulation will not have a significant economic impact upon a substantial number of small entities. This rulemaking merely clarifies the circumstances under which DEA registrations may be surrendered.

Paperwork Reduction Act

This action does not impose a new collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521. The forms discussed in this rulemaking are available to be utilized by registrants on a voluntary basis under specific law enforcement circumstances and are otherwise internal to DEA.

This proposed rulemaking does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

Executive Order 13175

This proposed rule will not have tribal implications and will not impose substantial direct compliance costs on Indian tribal governments.

Unfunded Mandates Reform Act of 1995

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $136,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532.

Congressional Review Act

This rulemaking is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act) (5 U.S.C. 801-808). This rule will not result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation or on the ability of U.S.-based companies to compete with foreign-based companies in domestic and export markets.

2. In § 1301.52, paragraph (a) is revised to read as follows:§ 1301.52 Termination of registration; transfer of registration; distribution upon discontinuance of business.

(a) Except as provided in paragraph (b) of this section, the registration of any person, and any modifications of that registration, shall terminate, without any further action by the Administration, if and when such person dies, ceases legal existence, discontinues business or professional practice, or surrenders a registration. Any registrant who ceases legal existence or discontinues business or professional practice shall notify the Administrator promptly of such fact. In the case of a surrender, termination shall occur upon receipt by any employee of the Administration of a duly executed DEA form 104 or any signed writing indicating the desire to surrender a registration.

PART 1309—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS, AND EXPORTERS OF LIST I CHEMICALS3. The authority citation for part 1309 continues to read as follows:Authority:

4. In § 1309.62, paragraph (a) is revised to read as follows:§ 1309.62 Termination of registration.

(a) The registration of any person shall terminate, without any further action by the Administration, if and when such person dies, ceases legal existence, discontinues business or professional practice, or surrenders a registration. In the case of a surrender, termination shall occur upon receipt by any employee of the Administration of a duly executed DEA form 104c or any signed writing indicating the desire to surrender a registration. Any registrant who ceases legal existence or discontinues business or professional practice or wishes to surrender a registration shall notify the Special Agent in Charge of the Administration in the area in which the person is located of such fact and seek authority and instructions to dispose of any List I chemicals obtained under the authority of that registration.

The Food and Drug Administration (FDA) is announcing that it has determined, after conducting a review of its existing regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the Agency to preempt State law, that three FDA regulatory preambles contain or refer to statements about preemption that are not legally justified. FDA conducted this review in response to the President's May 20, 2009, “Memorandum for the Heads of Executive Departments and Agencies,” which outlined the Administration's policy on preemption, in keeping with the principles in Executive Order 13132 on Federalism. The President's memorandum included a directive that such a review be conducted. FDA is also taking this opportunity to clarify certain preamble statements related to preemption resulting from express preemption provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning nonprescription drugs and food labeling.

On January 24, 2006 (71 FR 3922), FDA published a final rule entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products” (physician labeling rule). In the preamble to the physician labeling rule, FDA discussed its views on the preemptive effect of both the regulation's codified provisions and, more generally, the FD&C Act. In addition, FDA subsequently published two final rules with preambles that referenced the preemption discussion in the physician labeling rule. See “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile” (72 FR 73589, 73595, December 28, 2007); “Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices” (73 FR 49603, 49605-49606, August 22, 2008).

In its decision in Wyeth v. Levine, the Supreme Court addressed the preamble to the physician labeling rule and provided additional guidance in evaluating the preemptive effect of the FD&C Act and FDA regulations. 129 S. Ct. 1187 (2009). In this case, the Court upheld a State tort claim that was based on the manufacturer's failure to provide adequate warnings on the labeling of one of its prescription drug products. The Court held that the State claim was not preempted by the FD&C Act or FDA's labeling requirements, despite the Agency's position in the preamble to the physician labeling rule that such claims frustrate its statutory mandate.

According to the Court, FDA's position “does not merit deference,” in part, because it is “at odds with what evidence we have of Congress' purposes.” Id. at 1201. The Court found that Congress's “silence on the [preemption] issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” Id. at 1200. While the Court acknowledged that “some state-law claims might well frustrate the achievement of congressional objectives,” it found that “failure-to-warn claims” such as the one at issue do not “obstruct the federal regulation of drug labeling.” Id. at 1204. The Court also noted that the manufacturer did not avail itself of FDA regulations that permit changes to a drug's labeling. Id. at 1996-97. And “absent clear evidence that the FDA would not have approved” the type of warning deemed necessary by the State claim, the Court was not willing to “conclude that it was impossible” for the manufacturer “to comply with both federal and state requirements.” Id. at 1198.

In light of the Supreme Court's decision in Wyeth, FDA has concluded that the position on preemption articulated in the preamble to the physician labeling rule, and subsequently referred to in the preambles of the other two rules cited previously in this document, cannot be justified under legal principles governing preemption. The codified provisions in these rules, however, do not include any statements about preemption and would not preempt State law beyond governing principles of preemption. FDA's conclusion about the regulatory preambles, therefore, does not affect the validity or operation of the codified provisions in these three final rules.

FDA also would like to clarify past preamble statements related to preemption resulting from certain express preemption provisions in the FD&C Act concerning nonprescription drugs and food labeling. Some preamble statements in regulations on nonprescription drugs contain the following language: “Currently, [Section 751(a) of the FD&C Act (21 U.S.C. 379r(a))] operates to preempt States from imposing requirements related to the regulation of nonprescription drug products (See section 751(b) through (e) of the act for the scope of the express preemption provision, the exemption procedures, and the exceptions to the provision) * * *. Although this final rule would have a preemptive effect, in that it would preclude States from issuing requirements related to these OTC * * * drug products that are different from or in addition to, or not otherwise identical with a requirement in the final rule, this preemptive effect is consistent with what Congress set forth in section 751 of the act. Section 751(a) of the act displaces both State legislative requirements and State common law duties * * *.”

(See, e.g., 74 FR 9759, March 6, 2009; 73 FR 6015, February 1, 2008; 72 FR 71769, December 19, 2007; 72 FR 14669, March 29, 2007; 72 FR 9849, March 6, 2007; 71 FR 43358, August 1, 2006). This language could be read to suggest that FDA does not read section 751 of the FD&C Act as a whole and gives more significance to some provisions, e.g., subsection 751(a), than others, e.g., subsection 751(e) (which makes clear that section 751 does not affect any action under a state's product liability law). FDA now clarifies that it does read section 751 of the FD&C Act as a whole, in that each subsection must be read together with the other subsections.

In addition, FDA is now clarifying preamble statements in regulations on food labeling that contain the following language: “Although this rule has a pre-emptive effect, in that it would preclude states from issuing any * * * requirements * * * that are not identical to those required by the final rule, this pre-emptive effect is consistent with what Congress set forth in Section 403A of the Act [21 U.S.C. 343-1].” (See, e.g., 74 FR 2443, January 15, 2009). Although this language reflects the statutory language in section 403A of the FD&C Act, as codified at 21 U.S.C. 343-1, it does not acknowledge the applicability limitation set forth in section 6(c)(2) of the Nutrition Labeling and Education Act (NLEA), which was not codified. Section 6(c)(2) of the NLEA provided that section 403A of the FD&C Act “shall not be construed to apply to any requirement respecting a statement on the labeling of food that provides for a warning concerning the safety of the food or component of the food” (Pub. L. 101-535, section 6, 104 Stat. 2353 (1990)). FDA clarifies that its past discussions of section 403A of the FD&C Act should have included the language of section 6(c)(2) of the NLEA.

EPA is promulgating significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 36 chemical substances which were the subject of premanufacture notices (PMNs). Four of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 36 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

DATES:

This rule is effective on December 5, 2011. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (E.S.T.) on October 19, 2011.

Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before November 4, 2011 (see Unit VI. of the SUPPLEMENTARY INFORMATION).

For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2010-1075, by one of the following methods:

• Hand Delivery: OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2010-1075. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2010-1075. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

SUPPLEMENTARY INFORMATION:I. General InformationA. Does this action apply to me?

You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this rule. Potentially affected entities may include, but are not limited to:

• Manufacturers, importers, or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in § 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after November 4, 2011 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. BackgroundA. What action is the agency taking?

EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register of April 24, 1990 (55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

B. What is the agency's authority for taking this action?

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use. Persons who must report are described in § 721.5.

C. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

III. Significant New Use Determination

Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.

To determine what would constitute a significant new use for the 36 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, taking into consideration the four bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Substances Subject to This Rule

EPA is establishing significant new use and recordkeeping requirements for 36 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information).

• CFR citation assigned in the regulatory text section of this rule.

The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture and importation volume) and other uses designated in this rule may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

This rule includes 4 PMN substances (P-06-36, P-06-37, P-09-146 and P-09-147) for which EPA determined, pursuant to TSCA section 5(e), that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal may present an unreasonable risk of injury to human health or the environment. Accordingly, these substances are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I). Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) consent order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) consent orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 721.30 requests to use the NCELs approach for SNURs are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) consent order for the same chemical substance.

This rule also includes SNURs on 32 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so-called “non-5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) Are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.

Basis for TSCA section 5(e) consent order: The PMN states that the substances will be used as colorants for polymers and industrial coatings. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that the substances may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: Use of personal respiratory equipment, including a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an Assigned Protection Factor (APF) of at least 10, or compliance with a NCEL of 1.5 mg/m3 as an 8-hour time weighted average; establishment of a hazard communication program; and restricts the company from manufacturing the PMN substances with a d10 particle size less than 100 nanometers, where d10 particle size presents the particle size, as determined by laser light scattering, at which 10 percent by weight of the substance measured is smaller; and corresponding recordkeeping. The SNUR designates as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on structural activity relationship analysis derived from test data on structurally similar respirable, poorly soluble particulates, the PMN substances may cause lung overload and fibrosis in workers exposed to the PMN substances by the inhalation route.

Recommended testing: EPA has determined that the following test would help characterize the human health effects of the PMN substances: A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats. The testing should include a 60-day recovery period to assess the progression or regression of any lesions; and include special attention to histopathology (inflammation and cell proliferation) of the lung tissues and to various parameters of the bronchoalveolar lavage fluid (BALF), e.g., marker enzyme activities, total protein content, total cell count, cell differential, and cell viability. The order does not require submission of the aforementioned information at any specified time or production volume. However, the order's restrictions on manufacturing, import, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.

Basis for action: The PMN states that the generic (non-confidential) uses of the substance will be as a curative to be used with epoxy resin; a curative to be used with isocyanates in urethane systems; and an intermediate for synthesis of epoxy resins. Based on ecological structure-activity relationship (EcoSAR) analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 part per billion (ppb) of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10232.

PMN Number P-08-704

Chemical name: Linear alkyl epoxide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) uses of the substance will be as site-limited intermediates for personal care ingredients and foam control agents. Based on EcoSAR analysis of test data on analogous epoxides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for action: The PMN states that the substance will be used as an industrial intermediate. Based on test data on the PMN substance, and EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 6 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 6 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. Testing should be performed using the flow-through method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10234.

PMN Number P-09-72

Chemical name: Phenol, 2-ethoxy-4-(ethoxymethyl)-.

CAS number: 71119-07-8.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a perfumery ingredient. Based on EcoSAR analysis of test data on analogous phenols, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10235.

PMN Number P-09-139

Chemical name: 1-Propanamine, 3-[2-(2-methoxyethoxy)ethoxy]-.

CAS number: 91933-40-3.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a dispersant. Based on test data on an analogous substance submitted under TSCA section 8(e), EPA identified the following toxicity concerns from exposure to the PMN substance: Irritation to eyes; sensitization and corrosion to skin; and irritation to mucous membranes, lungs, and the gastrointestinal tract. For the uses described in the PMN, worker exposure and general population exposure are limited. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. However, EPA has determined that use of the substance other than as described in the PMN, or use of the substance in a consumer product, may result in significant human exposures. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of an acute oral toxicity test (OPPTS Test Guideline 870.1100 or Organisation for Economic Co-operation and Development (OECD) Test Guideline 425); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) via the intraperitoneal route; and a repeated dose 28-day oral toxicity study in rodents (OPPTS Test Guideline 870.3050 or OECD Test Guideline 407) would help characterize the human health effects of the PMN substance. Testing should be performed on the neutralized PMN substance. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for TSCA section 5(e) consent order: The PMNs state that the generic (non-confidential) use of the substances will be as adhesives. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that the substances may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: Restrictions on formaldehyde residuals and polymer composition in the PMN substances; testing of representative samples at new manufacturing facilities; development and implementation of a written control plan for analysis and compliance with specified chemical composition limits; use only as listed in the consent order; no processing or distribution of the PMNs except when processed under specified conditions, where the PMNs are irreversibly cured into a thermoset polymer matrix; and maintaining certain records. The SNUR designates as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on physical-chemical properties, the PMN substances are expected to be absorbed from the lung and low molecular weight fractions are expected to be poorly absorbed from the gastrointestinal tract. Further, the PMN substances are not expected to be absorbed through the skin. EPA identified concerns for respiratory tract irritation, coughing; skin irritation and redness; eye irritation, watering, and redness; sensitization and severe allergic reactions. Further, based on test data on formaldehyde, a component of the PMN substances and regarded by EPA and International Agency for Research on Cancer (IARC) to be a carcinogen, EPA predicts human carcinogenicity.

Recommended testing: EPA has determined that the following test would help characterize the human health effects of the PMN substances: Determining formaldehyde concentration in air from wood products, using a large scale chamber (American Society for Testing and Materials International (ASTM) Test Guideline E1333-10 or its equivalent) to demonstrate that formaldehyde emissions are equal to or less than 0.04 parts per million (ppm). The order does not require submission of the aforementioned information at any specified time or production volume. However, the order's restrictions on manufacturing, import, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.

Basis for action: The PMNs state that the use of the substances will be as acid dyes for coloring anodized aluminum. Based on test data on analogous substances including Beta-naphthylamine and chromium, EPA determined that the PMN substances may cause blood toxicity (methemoglobinemia), male reproductive toxicity, developmental toxicity, mutagenicity, and oncogenicity to workers and the general public exposed to the PMN substances via the lung or gastrointestinal tract. For the use described in the PMNs, worker inhalation exposure is unlikely, as the substances are imported, processed, and used as a wet press cake (greater than 30 percent water). Significant general population exposure is unlikely, as significant inhalation and drinking water exposures are not expected. Therefore, EPA has not determined that the proposed import, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that domestic manufacture, use of the substances other than as described in the PMNs, or the import, processing, or use of the substances in a powder or solid form (other than as a wet press cake that is comprised of greater than 30 percent water), may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of a bacterial reverse mutation test (OPPTS Test Guideline 870.5100) with the prival modification with a concurrent positive control; and an unscheduled DNA synthesis in mammalian cells in culture (OPPTS Test Guideline 870.5550) in rat hepatocytes on the Beta-naphthylamine reduction product would help characterize the human health effects of the PMN substances. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CAS numbers: (P-09-154) Not available; (P-09-155) not available; and (P-09-156) not available.

Basis for action: The PMNs state that the generic (non-confidential) uses of the substances will be as a processing additive intermediate (P-09-154 and P-09-155) and as a processing additive (P-09-156). Based on EcoSAR analysis of test data on analogous alkoxysilanes, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance (P-09-154) and 6 ppb of the PMN substance (P-09-156) in surface waters. Based on test data on analogous alkoxysilanes and thiols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance (P-09-155) in surface waters. As described in the PMNs, the substances will not be released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability—CO2 in sealed vessels test (OPPTS Test Guideline 835.3140); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. Testing should be performed on P-09-155. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for action: The PMNs state that the substances will be used as intermediates in the manufacture of a polyurethane flame retardant. Based on the alkylating activity of the PMN substances, EPA has concerns for oncogenicity, mutagenicity, developmental toxicity, dermal and respiratory sensitization, and irritation to all tissues. Additionally, the Agency has concern for liver toxicity, kidney toxicity, heart toxicity, developmental toxicity, and neurotoxicity based on test data for analog substances submitted to the Agency under TSCA section 8(e). Based on EcoSAR analysis of test data on structurally similar aliphatic amines, EPA predicts toxicity to aquatic organisms at concentrations that exceed 8 ppb in surface waters. As described in the PMN, significant worker dermal and inhalation exposure is unlikely for the use described in the PMN due to the use of personal protective equipment and engineering controls. Further, significant general population and environmental exposure is unlikely as the substances are not released to water. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of these substances may present an unreasonable risk. EPA has determined, however, that use of the substances other than as intermediates in the manufacture of a polyurethane flame retardant, use of the substances without the use of impervious gloves where there is potential for dermal exposure, or any use of the substances resulting in release to surface waters may cause significant adverse health or environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate, acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substances. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentration. Testing should be performed on P-09-193. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for action: The PMN states that the substance will be used as an intermediate in the manufacture of nonionic surfactants. Based on EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 14 ppb of the PMN substance in surface waters. For the use described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 14 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as an intermediate in the manufacture of nonionic surfactants may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10245.

PMN Number P-09-234

Chemical name: Alkylpolyhydroxy polymer (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a drilling fluid additive. Based on EcoSAR analysis of test data on analogous alkyl ethoxylate nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 56 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10246.

PMN Number P-09-258

Chemical name: Bis-phenoxyethanol fluorene diacrylate (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a raw material in ultra violet (UV) curable inks and coatings. EPA identified health and environmental concerns because the substance may be a persistent, bio-accumulative, and toxic (PBT) chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substance will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 5,000. Also, based on test data on analogous acrylates, EPA believes exposure to the PMN substance may cause systemic human health effects and predicts toxicity to aquatic organisms. As described in the PMN, significant worker exposure is unlikely and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any predictable or purposeful release containing the PMN substance into the waters of the United States may cause serious health effects and significant environmental effects, since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10247.

PMN Number P-09-259

Chemical name: Aromatic bromide (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a synthetic intermediate. EPA identified health and environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999). EPA estimates that the PMN substance will persist in the environment more than six months and estimates a bioaccumulation factor of greater than or equal to 5,000. Also, based on test data on analogous brominated aromatics and neutral organics (aryl halides), EPA believes exposure to the PMN substance may cause systemic human health effects and predicts toxicity to aquatic organisms. As described in the PMN, significant worker exposure is unlikely and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN or any predictable or purposeful release containing the PMN substance into the waters of the United States may cause serious health effects and significant environmental effects, since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10248.

PMN Number P-09-316

Chemical name: Disubstituted phenol (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on test data on analogous anilines and phenols, as well as on test data submitted to the Agency under TSCA section 8(e), EPA identified concerns for liver toxicity, mutagenicity, carcinogenicity, developmental toxicity, neurotoxicity, and male reproductive system toxicity to workers from inhalation exposure to the PMN substance. Additionally, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb of the PMN substance in surface waters. For the use described in the PMN, significant worker exposure is unlikely due to the use of personal protective equipment. Furthermore, significant environmental exposure is unlikely as the substance is not released to surface water resulting in surface water concentrations that exceed 6 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use other than as a chemical intermediate, or exceedance of the manufacture and import limit of 100 kg per year may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) prolonged exposure; a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) using rainbow trout and a 60-day minimum duration; and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10249.

PMN Number P-09-356

Chemical name: Zirconium lysine complex (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesion promoter and corrosion inhibitor. Based on EcoSAR analysis of test data on analogous inorganic zirconium compounds, EPA predicts toxicity to aquatic organisms at concentrations that exceed 120 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 120 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 120 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for action: The PMN states that the substance will be used as an intermediate for a product used as a component of a multipurpose additive in gasoline. Based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 400 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 400 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as an intermediate could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i).

Recommended testing: EPA has determined that the results of an aerobic and anaerobic transformation in aquatic sediment systems (OECD Test Guideline 308); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. EPA also recommends performing the fate testing first as the results may mitigate the need for further toxicity testing or change the testing requirements. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10251.

PMN Number P-09-373

Chemical name: Thiosulfuric acid (H2S2O3), manganese(2+) salt (1:1).

CAS number: 1033050-53-1.

Basis for action: The PMN states that the substance will be used as a micronutrient manganese source for selected agricultural crops. Based on EcoSAR analysis of test data on analogous manganese salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 400 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 400 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 400 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with mean measured concentrations. Algal testing should be performed using the static method with mean measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a seed coating to provide micronutrients. Based on EcoSAR analysis of test data on analogous soluble complexes of zinc, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 34 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 34 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 34 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability-CO2 in sealed vessels (headspace test) (OECD Test Guideline 310); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends performing the fate testing first as the results may mitigate the need for further toxicity testing or change the testing requirements. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10253.

PMN Number P-09-390

Chemical name: Substituted acrylamide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a raw material. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous amides and acrylamides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 21 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 21 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 21 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075) using the flow-through method with measured concentrations, and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) using the static method with measured concentrations would help characterize the environmental effects of the PMN substance. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10254.

PMN Number P-09-400

Chemical name: Vinyl carboxylic acid ester (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a monomer. Based on test data on the PMN substance and analogous vinyl esters, EPA identified concerns for dermal sensitization; dermal irritation; mutagenicity; neurotoxicity; and blood, liver, kidney, spleen, brain, testes, developmental, and reproductive toxicity to the general population if exposed to the PMN substance. In addition, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 15 ppb of the PMN substance in surface waters. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii) and (b)(4)(i). At the production volume stated in the PMN, general population exposure is limited. Further, as described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 15 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk under TSCA section 5(e). However, EPA has determined that annual manufacture (including importation) of this PMN substance at volumes greater than 100,000 kilograms per year may result in significant human exposures. Further, EPA has determined that any use of the substance resulting in surface water concentrations exceeding 15 ppb may cause significant adverse environmental effects.

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance. Aquatic toxicity testing should be performed using the flow-through method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for action: The PMN states that the substance will be used as a co-photoinitiator for UV-curable pigmentation inks; co-photoinitiator for photoresists, optical fibers, and printed plates; co-photoinitiator for UV-curable coatings; and co-photoinitiator for UV-curable adhesives and other coatings. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous aliphatic amines and esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3100); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. Testing should be performed using the flow-through method with mean measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. EPA also recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10256.

PMN Number P-09-532

Chemical name: Butyl aromatic bisurea (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a sealant. Based on EcoSAR analysis of test data on analogous substituted urea, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance will not be released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for action: The PMNs state that the substances will be used as synthetic intermediates. EPA has identified health and environmental concerns because the substances may be PBT chemicals, based on physical/chemical properties of the PMN substances, as described in the New Chemicals Program's PBT Category (64 FR 60194; November 4, 1999). EPA estimates that the PMN substances will persist in the environment more than two months and estimates bioaccumulation factors that are greater than or equal to 5,000. Also, based on test data on analogous poly-aromatic hydrocarbons, EPA predicts chronic adverse human health effects. As described in the PMNs, significant worker exposure is unlikely and the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any predictable or purposeful release containing the PMN substances into the waters of the United States may cause serious health effects and significant adverse environmental effects, since the PMN substances have been characterized by EPA as PBT. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii) and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substances. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for action: The PMN states that the substance will be used as a site-limited starting material in novel polymer synthesis reactions. EPA has identified health and environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999). EPA estimates that the PMN substance will persist in the environment more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. In addition, based on the potential for the PMN to be an alkylating agent, EPA identified concerns for oncogenicity, developmental toxicity, sensitivity, and corrosion to all tissues from dermal and respiratory exposure. Further, based on EcoSAR analysis of test data on analogous benzyl halides, EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, significant worker exposure is unlikely due to the use of adequate dermal and respiratory protection and the substance is not expected to be released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any predictable or purposeful release containing the PMN substance into the waters of the United States may cause serious health effects and significant adverse environmental effects, since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT Category (64 FR 60914; November 4, 1999) should help characterize the PBT attributes of the PMN substance. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as chain extenders. Based on test data on the PMN substances and the expected hydrolysis product, EPA identified concerns for carcinogenicity, dermal sensitization, blood effects, reproductive toxicity, and neurotoxicity to workers and the general population exposed dermally or by inhalation to the PMN substances. In addition, based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substances in surface waters. As described in the PMNs, worker exposure will be minimal due to the use of adequate personal protective equipment, general population inhalation and dermal exposure is not expected, and the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances without the use of impervious gloves where there is potential for dermal exposure, annual manufacture (including importation) of each of the PMN substances at volumes greater than 20,000 kilograms, or any use of the substances resulting in release to surface waters may cause serious health effects and/or significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a two-generation reproduction toxicity test (OECD Test Guideline 416); a ready biodegradability test (OPPTS Test Guideline 835.3110); a porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity mitigated by humic acid test (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test; freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substances. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Testing should be performed on P-09-589. EPA recommends that the fate testing be performed first as the results may mitigate the need for further testing or change the testing requirements. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

Basis for action: The PMN states that the substance will be used as a raw material (reactant) for production of intermediate for a photographic chemical. Based on test data on the PMN substance, and test data submitted under TSCA section 8(e) on analogous aminophenols, EPA identified concerns for irritation to the eye and skin, mutagenicity, neurotoxicity, developmental, liver, blood, and reproductive toxicities to workers and members of the general population if exposed to the PMN substance. In addition, based on EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. For the uses described in the PMN, significant worker exposure is unlikely, as dermal/inhalation exposure is not expected; the substance is not released to surface waters; and the substance is not expected to result in significant exposure to the general population. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN or any use of the substance resulting in release to surface waters may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity with the reproduction/development toxicity screening test (OPPTS Test Guideline 870.3650); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test; freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10263.

PMN Number P-10-343

Chemical name: Polycarbocyclic methacrylate (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymeric component. Based on EcoSAR analysis of test data on analogous methacrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guidelines 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10264.

V. Rationale and Objectives of the RuleA. Rationale

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 4 of the 36 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160 (see Unit II.).

In the other 32 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.

B. Objectives

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

• EPA will receive notice of any person's intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.

• EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use.

• EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.

• EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/newchems/pubs/invntory.htm.

VI. Direct Final Procedures

EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), the effective date of this rule is December 5, 2011 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before November 4, 2011.

If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before November 4, 2011, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.

This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment.

VII. Applicability of Rule to Uses Occurring Before Effective Date of the Rule

Significant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule, October 5, 2011.

To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. TSCA section 5(e) consent orders have been issued for 4 chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which EPA is designating as significant new uses. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no other person may commence such activities without first submitting a PMN. For chemical substances for which an NOC has not been submitted at this time, EPA concludes that the uses are not ongoing. However, EPA recognizes that prior to the effective date of the rule, when chemical substances identified in this SNUR are added to the TSCA Inventory, other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 23 of the 36 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions (per §§ 720.25 and 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of this direct final rule rather than as of the effective date of the rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements because a person could defeat the SNUR by initiating the significant new use before the rule became effective, and then argue that the use was ongoing before the effective date of the rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires.

EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person meets the conditions of advance compliance under § 721.45(h), the person is considered exempt from the requirements of the SNUR.

VIII. Test Data and Other Information

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are:

1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).

2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).

In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. The American Society for Testing and Materials International (ASTM) standards are available at http://www.astm.org/Standard/index.shtml.

In the TSCA section 5(e) consent orders for four of the chemical substances regulated under this rule, EPA has established restrictions in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These restrictions will not be removed until EPA determines that the unrestricted use will not present an unreasonable risk of injury or result in significant or substantial exposure or environmental release. This determination is usually made based on the results of the required or recommended toxicity tests.

The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

• Potential benefits of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

IX. Procedural Determinations

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1). Today's rules cross-reference § 721.1725(b)(1) (which is similar to the procedure in § 721.11, for situations where the chemical identity of the chemical substance subject to a SNUR is CBI) in each SNUR that includes specific significant new uses that are CBI.

Under these procedures a manufacturer, importer, or processor may request that EPA determine whether a proposed use would be a significant new use under the rule. The manufacturer, importer, or processor must show that it has a bona fide intent to manufacture, import, or process the chemical substance and must identify the specific use for which it intends to manufacture, import, or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture, import, or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers, importers, and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture, import, or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

X. SNUN Submissions

According to § 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in § 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in §§ 721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2010-1075.

XII. Statutory and Executive Order ReviewsA. Executive Order 12866

This rule establishes SNURs for several new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a handful of notices per year. For example, the number of SNUNs was four in Federal fiscal year 2005, eight in FY2006, six in FY2007, eight in FY2008, and seven in FY2009. During this five-year period, three small entities submitted a SNUN. In addition, the estimated reporting cost for submission of a SNUN (see Unit XI.) is minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this rule. As such, EPA has determined that this rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

E. Executive Order 13132

This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This rule does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this rule.

G. Executive Order 13045

This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

H. Executive Order 13211

This action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

XIII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

2. The table in § 9.1 is amended by adding the following sections in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:§ 9.1 OMB approvals under the Paperwork Reduction Act.40 CFR citationOMB

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as rutile, tin zinc, calcium-doped (PMN P-06-36; CAS No. 389623-01-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance that have been incorporated into a polymer, glass, dispersion, cementitious matrix, or a similar incorporation.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(4), (a)(5), (a)(6)(i), (b) (concentration set at 1.0 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of 10 meet the minimum requirements for § 721.63(a)(5):

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(1) As an alternative to the respiratory requirements listed in paragraph (a)(2)(i), a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for these substances. The NCEL is 1.5 mg/m3 as an 8-hour time-weighted-average for both chemical substances combined. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (manufacture of the substances with a particle size less than 100 nanometers, where d10 particle size presents the particle size, as determined by laser light scattering, at which 10 perecent by weight of the substance measured is smaller).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as rutile, tin zinc, sodium-doped (PMN P-06-37; CAS No. 389623-07-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance that have been incorporated into a polymer, glass, dispersion, cementitious matrix, or a similar incorporation.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(4), (a)(5), (a)(6)(i), (b) (concentration set at 1.0 percent), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of 10 meet the minimum requirements for § 721.63(a)(5):

(E) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half-face or full-face).

(1) As an alternative to the respiratory requirements listed in paragraph (a)(2)(i), a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for these substances. The NCEL is 1.5 mg/m3 as an 8-hour time-weighted-average for both chemical substances combined. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (manufacture of the substances with a particle size less than 100 nanometers, where d10 particle size presents the particle size, as determined by laser light scattering, at which 10 percent by weight of the substance measured is smaller).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as n-arylamino-phenol-formaldehyde condensate (PMN P-08-694) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as linear alkyl epoxide (PMN P-08-704) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydroxy-chloro-cyclopropyl-heteromonocyclic carboxylic acid (PMN P-09-61) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phenol, 2-ethoxy-4-(ethoxymethyl)- (PMN P-09-72; CAS No. 71119-07-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-propanamine, 3-[2-(2-methoxyethoxy)ethoxy]- (PMN P-09-139; CAS No. 91933-40-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as formaldehyde, polymers with acetone-phenol reaction products and phenol, sodium salts (PMN P-09-146; CAS No. 1065544-88-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance that have been completely reacted (cured).

(A) Manufacture or import of the PMN substance only where the maximum unbound formaldehyde residual levels and typical polymer weight to weight composition ratios are as specified in the TSCA section 5(e) consent order.

(B) Upon start-up of manufacture of the PMN at any new facility, conduct the American Society for Testing and Materials International (ASTM) E1333-10 test or its equivalent on a representative sample of the finished cured resin product, demonstrating that formaldehyde emissions are less than or equal to 0.04 ppm.

(C) Development and implementation of a written control plan that includes analysis of representative samples to ensure compliance with (a)(2)(i)(A) and (a)(2)(i)(B) of this section.

(D) Manufacturing, processing, distribution, or use of the PMN substance only as described in the TSCA section 5(e) consent order.

(E) Processing or distribution for processing only under the conditions described in the TSCA section 5(e) consent order and which are capable of irreversibly curing the PMN substance into a thermoset polymer matrix.

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as formaldehyde, polymers with acetone-phenol reaction products and phenol, potassium sodium salts (PMN P-09-147; CAS No. 1072227-60-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance that have been completely reacted (cured).

(A) Manufacture or import of the PMN substance only where the maximum unbound formaldehyde residual levels and typical polymer weight to weight composition ratios are as specified in the TSCA section 5(e) consent order.

(B) Upon start-up of manufacture of the PMN at any new facility, conduct the American Society for Testing and Materials International (ASTM) E1333-10 test or its equivalent on a representative sample of the finished cured resin product, demonstrating that formaldehyde emissions are less than or equal to 0.04 ppm.

(C) Development and implementation of a written control plan that includes analysis of representative samples to ensure compliance with (a)(2)(i)(A) and (a)(2)(i)(B) of this section.

(D) Manufacturing, processing, distribution, or use of the PMN substance only as described in the TSCA section 5(e) consent order.

(E) Processing or distribution for processing only under the conditions described in the TSCA section 5(e) consent order and which are capable of irreversibly curing the PMN substance into a thermoset polymer matrix.

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as trivalent chromium complexes of a substituted beta-naphthol amine azo dye (PMNs P-09-152 and P-09-153) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (j) (acid dye for coloring anodized aluminum). Also, requirements as specified in § 721.80(v)(1), (v)(2), (w)(1), (w)(2), (x)(1), and (x)(2), except that importing, processing, and use of the PMN substance in the form of a wet press cake containing greater than 30 percent water does not require submission of a SNUN.

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as olefinic carbocycle, reaction products with alkoxysilane (PMN P-09-154) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as olefinic carbocycle, reaction products with alkoxysilane, sulfurized (PMN P-09-155) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as olefinic carbocycle, reaction products with alkoxysilane, polysulfurized (PMN P-09-156) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphonic acid, P-[2-[bis(2-hydroxyethyl)amino]ethyl]-, bis(2-chloroethyl) ester (PMN P-09-193; CAS No. 55088-28-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1 percent), and (c).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (intermediate in the manufacture of a polyurethane flame retardant).

(iii) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphonic acid, P-[2-[bis(2-hydroxyethyl)amino]ethyl]-, 2-[bis(2- chloroethoxy)phosphinyl]ethyl 2-chloroethyl ester (PMN P-09-195; CAS No. 1094213-37-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1 percent), and (c).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (intermediate in the manufacture of a polyurethane flame retardant).

(iii) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as branched and linear fatty alcohol ethoxylate (PMN P-09-207) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylpolyhydroxy polymer (PMN P-09-234) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as bis-phenoxyethanol fluorene diacrylate (PMN P-09-258) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic bromide (PMN P-09-259) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as disubstituted phenol (PMN P-09-316) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as zirconium lysine complex (PMN P-09-356) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, reaction products with alkanolamine (PMN P-09-366) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as thiosulfuric acid (H2S2O3), manganese(2+) salt (1:1) (PMN P-09-373; CAS No. 1033050-53-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted acrylamide (PMN P-09-390) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as vinyl carboxylic acid ester (PMN P-09-400) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzoic acid, 4-(dimethylamino)-, 1,1′-[(methylimino)di-2,l-ethanediyl] ester (PMN P-09-479; CAS No. 925246-00-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as butyl aromatic bisurea (PMN P-09-532) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic hydrocarbon (PMN P-09-535) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halogenated aromatic hydrocarbon (PMN P-09-540) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzene, 1,3-bis(1-chloro-1-methylethyl)- (PMN P-09-552; CAS No. 37133-18-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as oxime, di-Me silane (PMN P-09-589) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1 percent), and (c).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as oxime, Me vinyl silane (PMN P-09-590) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1 percent), and (c).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phenol, 4-(1,1-dimethylethyl)-2-nitro- (PMN P-09-634; CAS No. 3279-07-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (raw material (reactant) for production of intermediate for a photographic chemical).

(ii) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polycarbocyclic methacrylate (PMN P-10-343) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

This regulation establishes tolerances for residues of prothioconazole in or on multiple commodities which are identified and discussed later in this document. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective October 5, 2011. Objections and requests for hearings must be received on or before December 5, 2011, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2011-0053. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0053 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 5, 2011. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0053, by one of the following methods:

In the Federal Register of March 29, 2011 (76 FR 17375) (FRL-8867-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PPs 0F7714 and 0F7715) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.626 be amended by establishing tolerances for residues of the fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione and its desthio metabolite, in or on the raw or processed agricultural commodity rice, grain at 0.25 parts per million (ppm); rice, hulls at 1.0 ppm; alfalfa, forage and alfalfa, hay at 0.02 ppm and potato, tuber at 0.02 ppm (PP 0F7714). In a separate petition (PP 0F7715) Bayer CropScience also proposed use of the currently established tolerances for residues of prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione and its desthio metabolite, in or on the raw agricultural commodities pea and bean, dried shelled, except soybean, subgroup 6C; soybean, forage; soybean, hay; soybean, seed; rice, seed to support the use of prothioconazole as a seed treatment on these crops. That notice referenced a summary of the petitions prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has determined that it is appropriate to modify the existing grain crop groups rather than establish separate rice grain and rice straw tolerances. The rice grain tolerance will now be covered by the modified tolerance of 0.35 ppm for grain, cereal group 15, except sweet corn and sorghum. Likewise, the rice straw tolerance will now be covered by the modified tolerance of 5.0 ppm for grain, cereal, forage, fodder, and straw, group 16, except sorghum; straw. Also, the EPA is establishing a tolerance for rice hulls at 0.90 ppm, instead of the proposed tolerance of 1.0 ppm. The reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for prothioconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with prothioconazole follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Prothioconazole has low acute toxicity by oral, dermal, and inhalation routes. It is not a dermal sensitizer, or a skin or eye irritant. Prothioconazole's metabolite, prothioconazole-desthio, also has low acute toxicity by oral, dermal, and inhalation routes. It is not a dermal sensitizer, or a skin irritant, but it is a slight eye irritant. The subchronic and chronic studies show that the target organs at the lowest observable adverse effects level (LOAEL) include the liver, kidney, urinary bladder, thyroid and blood. In addition, the chronic studies showed body weight and food consumption changes, and toxicity to the lymphatic and GI systems.

Prothioconazole and its metabolites may be developmental toxicants, producing effects including malformations in the conceptus at levels equal to or below maternally toxic levels in some studies; particularly those studies conducted using prothioconazole-desthio. Reproduction studies in the rat with prothioconazole and prothioconazole-desthio suggest that these chemicals may not be reproductive toxicants. Acute and subchronic neurotoxicity studies were conducted in the rat using prothioconazole. A developmental neurotoxicity study was conducted in the rat using prothioconazole-desthio.

The available data show that the prothioconazole-desthio metabolite produces toxicity at lower dose levels in subchronic, developmental, reproductive, and neurotoxicity studies as compared with prothioconazole and the two additional metabolites that were tested.

The available carcinogenicity and/or chronic studies in the mouse and rat, using both prothioconazole and prothioconazole-desthio, show no increase in tumor incidence. Therefore, EPA has concluded that prothioconazole and its metabolites are not carcinogenic, and are classified as “Not likely to be Carcinogenic to Humans” according to the 2005 Cancer Guidelines.

Specific information on the studies received and the nature of the adverse effects caused by prothioconazole as well as the no-observed-adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies are discussed in the final rule published in the Federal Register of May 28, 2010 (75 FR 29910) (FRL-8828-6).

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for prothioconazole used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of May 28, 2010 (75 FR 29910) (FRL-8828-6).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to prothioconazole and its metabolites and/or degradates, EPA considered exposure under the petitioned-for tolerances as well as all existing prothioconazole tolerances in 40 CFR 180.626. EPA assessed dietary exposures from prothioconazole in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA conducted a moderately refined acute dietary exposure assessment. Empirical processing factors, average field trial residues (since all of the plant commodities included in this assessment are blended food forms, except sweet corn), and livestock commodity residues derived from feeding studies and a reasonably balanced dietary burden (RBDB) were incorporated into the moderately refined acute assessment. The assessment also assumed 100 percent crop treated (PCT). Since no observed effects would be attributable to a single dose exposure for the general U.S. population (including infants and children), females 13-49 years of age was the only population subgroup included in the acute assessment.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA conducted a moderately refined chronic dietary exposure assessment. Empirical processing factors, average field trial residues, and livestock commodity residues derived from feeding studies and a reasonably balanced dietary burden (RBDB) were incorporated into the chronic assessment; 100 PCT was assumed.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or non-linear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear approach is used and a cancer RfD is calculated based on an earlier non-cancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized.

Based on the data summarized in Unit III.A., EPA has concluded that prothioconazole is “Not Likely to be Carcinogenic to Humans.” Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. Average residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for prothioconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prothioconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of prothioconazole for the acute dietary risk assessment, the estimated surface water concentration value of 94.7 parts per million (ppb) was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the estimated surface water concentration value of 84.3 ppb was used to assess the contribution to drinking water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Prothioconazole is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Prothioconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events. In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

Prothioconazole is a triazole-derived pesticide. Triazole-derived pesticides can form the common metabolite, 1,2,4-triazole and three triazole conjugates (triazole alanine, triazole acetic acid, and triazolylpyruvic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including prothioconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor (SF) for the protection of infants and children. The assessment included evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's risk assessment can be found in the propiconazole reregistration docket at http://www.regulations.gov, docket ID number EPA-HQ-OPP- 2005-0497 and an update to assess the addition of the commodities included in this action may be found in docket ID number EPA-HQ-OPP-2010-0621 in the document titled “Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address Tolerance Petitions for Metconazole.”

D. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is evidence of increased susceptibility following prenatal/or postnatal exposure in:

i. Rat developmental toxicity studies with prothioconazole as well as its prothioconazole-desthio and sulfonic acid K salt metabolites.

iii. A rat developmental neurotoxicity study with prothioconazole-desthio; and

iv. Multi-generation reproduction studies in the rat with prothioconazole-desthio. Effects include skeletal structural abnormalities, such as cleft palate, deviated snout, malocclusion, extra ribs, and developmental delays. Available data also show that the skeletal effects such as extra ribs are not completely reversible after birth in the rat, but persist as development continues.

Although increased susceptibility was seen in these studies, the Agency concluded that there is a low concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of prothioconazole because:

• Developmental toxicity NOAELs and LOAELs from prenatal exposure are well characterized after oral and dermal exposure;

• The off-spring toxicity NOAELs and LOAELs from postnatal exposures are well characterized; and

• The NOAEL for the fetal effect malformed vertebral body and ribs is used for assessing acute risk of females 13 years and older and, because it is lower than the NOAELs in other developmental studies, is protective of all potential developmental effects.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for prothioconazole is complete, including required functional immunotoxicity testing. The EPA began requiring functional immunotoxicity testing of all food and non-food use pesticides on December 26, 2007.

ii. There is an acceptable battery of neurotoxicity studies including a developmental neurotoxicity study. Although offspring neurotoxicity was found, characterized by peripheral nerve lesions in the developmental neurotoxicity studies on prothioconazole-desthio, the increase was seen only in the highest dose group at 105 mg/kg/day, was not considered treatment related, and a clear NOAEL was established for this study.

iii. Although increased susceptibility was seen in the developmental and reproduction studies, the Agency concluded that there is a low concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of prothioconazole for the reasons explained in Unit III.D.2.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment is moderately refined utilizing empirical processing factors, 100 PCT, average crop field trial residue levels, and livestock maximum residues. Results from ruminant feeding studies and poultry metabolism studies were used to determine the maximum residue levels for livestock commodities. The crop field trials were performed using maximum application rates and minimum pre-harvest intervals. Although the Agency is requiring extended confirmatory storage stability data; interim storage stability data do not indicate that residue concentrations decline and therefore the assessment should not underestimate risk from dietary exposure. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to prothioconazole in drinking water. These assessments will not underestimate the exposure and risks posed by prothioconazole.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

Based on the proposed and existing crop uses for prothioconazole, dietary aggregate exposures (i.e., food plus drinking water) are anticipated. There are no residential uses for prothioconazole and, therefore, no residential exposures are anticipated. Consequently, only dietary (food plus drinking water) exposures were aggregated for this assessment.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and drinking water to prothioconazole will occupy 24% of the aPAD for females 13-49 years of age, the only population group at risk for acute effects.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to prothioconazole from food and drinking water will utilize 21% of the cPAD for the general U.S. population and 62% of the cPAD for all infants <1 year old, the population group receiving the greatest exposure.

3. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, prothioconazole is not expected to pose a cancer risk to humans.

4. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to prothioconazole residues.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has established MRLs for residues of desthio-prothioconazole in barley at 0.2 ppm; oats, rye, and wheat at 0.05 ppm each; in the fodder (dry) of cereal grains at 5 ppm; and in the straw (dry) of cereal grains at 4 ppm. There are currently no established Mexican MRLs for prothioconazole. Canadian MRLs have been established for prothioconazole per se in/on several commodities, including barley (0.35 ppm), wheat (0.07 ppm). Harmonization of the proposed tolerances with the existing Codex for prothioconazole is not possible at this time because of differences in tolerance expression and use patterns. The MRL expression for Codex is prothioconazole-desthio and is thus not compatible with the U.S. tolerance definition, the sum of prothiocoanzole and prothioconazole-desthio. EPA generally includes the parent in all residue definitions for tolerance enforcement, whereas Codex routinely excludes the parent if it is shown to be a small part of the actual total residue. Prothioconazole is a minor component of the total residue on the crops tested. Much of the Codex cereal grain supervised field trial data are from Europe, where the use pattern is different resulting in lower measured residues.

The tolerance definition for plant commodities in Canada was recently changed and is now harmonized with the U.S. residue definition. The barley tolerance of Canada agrees with the U.S. tolerance for cereal grains (except sweet corn, sorghum, and rice) of 0.35 ppm. However, the Canada tolerance for wheat is lower (0.07 ppm) than the existing U.S. group tolerance. EPA establishes crop group tolerances, as opposed to individual commodity tolerances, whenever there are adequate data for the representative commodities of that group and proposed use. There must be an acceptable range of residues over all the representative commodities. Wheat falls under this crop group practice in this case. Canada does not routinely establish animal feed commodity tolerances, and therefore there are no harmonization issues with forage, stover, hay, and straw.

C. Revisions to Petitioned-For Tolerances

The proposed rice grain tolerance level of 0.25 ppm is lower than the existing tolerance level (0.35 ppm) for grain, cereal group 15, except rice and sweet corn and sorghum. The existing cereal grain group 15 tolerance excludes rice, but the present evaluation of rice field trial data allows expansion of that group to include rice. Therefore, in this action, EPA is revising the existing cereal group to read grain, cereal group 15 (except sweet corn and sorghum). Likewise, the rice straw tolerance level is lower than the existing tolerance level (5.0 ppm) for grain, cereal, forage, fodder, and straw, group 16, except sorghum and rice straw, and therefore this crop group is being revised to include rice straw. Also, the submitted data support a tolerance of 0.90 ppm for rice hulls as determined from the rice to hull processing factor (from the rice processing study) applied to the highest average field trial residue, or 4.4 × 0.19 ppm, or 0.9 ppm instead of the proposed tolerance of 1.0 ppm.

V. Conclusion

Therefore, tolerances are established for residues of prothioconazole (2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thion) and its metabolite prothioconazole-desthio (α-(1-chlorocyclopropyl)-α-[(2-chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol), in or on alfalfa, forage at 0.02 ppm; alfalfa, hay at 0.02 ppm, potato at 0.02 ppm and rice, hulls at 0.90 ppm. The existing tolerance for Grain, cereal, group 15, except sweet corn, sorghum, and rice is changed to Grain, cereal, group 15, except sweet corn and sorghum and the existing tolerance for Grain, cereal, forage, fodder and straw, group 16, except sorghum and rice; straw is changed to Grain, cereal, forage, fodder and straw, group 16, except sorghum, straw.

Further, seed treatment uses on soybean, dried shelled pea and bean (except soybean) subgroup 6C and rice are covered by existing and currently established tolerances for these commodities.

VI. Statutory and Executive Order Reviews

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the national government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

VII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

This regulation establishes a tolerance for residues of isopyrazam in or on banana. Syngenta Crop Protection, Inc., requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective October 5, 2011. Objections and requests for hearings must be received on or before December 5, 2011, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0906. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

SUPPLEMENTARY INFORMATION:I. General InformationA. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0906 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 5, 2011. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2009-0906, by one of the following methods:

In the Federal Register of February 4, 2010 (75 FR 5790) (FRL-8807-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9E7606) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the fungicide isopyrazam, in or on banana at 0.05 ppm parts per million (ppm). That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for isopyrazam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with isopyrazam follows:

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Isopyrazam is of low acute toxicity by the oral, dermal and inhalation routes, and is not a skin or eye irritant. The primary target organ for isopyrazam toxicity is the liver based on subchronic and chronic oral studies in the rat, mouse rabbit and dog. The principal effects observed in these studies are increased organ weight and centrilobular hepatocyte hypertrophy. Liver toxicity is usually accompanied by reductions in body weight and food consumption. Isopyrazam does not cause reproductive toxicity. Developmental effects (eye abnormalities) were observed in the absence of maternal toxicity in two range finding developmental toxicity studies in rabbits providing some evidence of sensitivity/susceptibility following pre- and/or postnatal exposure. Developmental studies in rats produced developmental effects but only at doses that were also maternally toxic. Acute and subchronic oral neurotoxicity studies in rats show no evidence of neurotoxicity. Effects characteristic of neurotoxicity (side-to-side head wobble, ataxia, reduced stability) were observed on day 2 in one subchronic oral study in dogs and at week 4 in a second subchronic dog study. These effects were not observed in the chronic dog study. However, EPA concluded for the following reasons that it is unlikely that there was a neurotoxic basis for these effects. First, the effects were seen only in a study not specifically conducted to identify neurotoxic potential and where detailed clinical and histopathological analyses for neurotoxic effects were not performed whereas isopyrazam showed no evidence of neurotoxicity in the available acute and subchronic neurotoxicity studies. Second, isopyrazam is not structurally similar to known neurotoxicants or neurotoxic classes of chemicals. Finally, its pesticidal mode of action does not demonstrate potential for neurotoxicity. Based on these findings, a developmental neurotoxicity study for isopyrazam is not required.

There is no evidence of immunotoxicity based on a 28-day dietary immunotoxicity study in rats. The lowest observed adverse effect level (LOAEL) for immunotoxicity was not identified and the no observed adverse effect level (NOAEL) for immunotoxicity is 1,356 milligrams/kilograms (mg/kg). The study NOAEL was 127 mg/kg/day, based on transient body weight loss and high liver weights at both 608 and 1,356 mg/kg/day. The toxicology database for isopyrazam does not show any evidence of treatment-related effects on the immune system. The overall weight of evidence suggests that this chemical does not directly target the immune system.

Isopyrazam is classified as “Likely to be Carcinogenic to Humans” based on tumors in male and female rats. Specific information on the studies received and the nature of the adverse effects caused by isopyrazam as well as the NOAEL and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in document “Isopyrazam Human Health Risk Assessment for the Establishment of a Tolerance for isopyrazam (SYN52043) Fungicide in/on Imported Banana,” on pp. 8-12 in docket ID number EPA-HQ-OPP-2009-0906.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern (LOC) to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed the NOAEL and the lowest dose at which adverse effects of concern are identified the LOAEL. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

PODs for incidental oral, dermal and inhalation exposure are not needed to assess risk for the requested tolerance on bananas because use of isopyrazam will only lead to dietary exposure, and have therefore not been selected for this risk assessment.

The acute POD of 30 mg/kg/day (NOAEL) was selected based on the NOAEL from a subchronic toxicity study in dogs. In that study, clinical signs of toxicity (side-to-side head wobble) were observed beginning on day 2 and continuing throughout the study in 1 of 4 male dogs at the LOAEL of 100 mg/kg/day. Transient clinical signs (side-to-side head wobble, ataxia, reduced stability) were also observed at 300 mg/kg/day in 3 of 4 male dogs on days 2 and 3 only. An uncertainty factor of 100x (10x to account for interspecies extrapolation and 10x for intraspecies variation) was applied to the NOAEL to obtain an aRfD of 0.30 mg/kg/day. This endpoint is considered to occur following a single dose and is applicable to the population of concern (general population, including infants and children). It is considered to be a very conservative endpoint since it is based on observations in 1/4 dogs and these acute clinical signs were not reproduced in a second 90-day study in dogs or in the chronic dog study. This endpoint is also protective of the effects seen at the limit dose (2,000 mg/kg/day) in the acute neurotoxicity study in rats (decreased rearing and locomotor activity) and the developmental effect (bilateral microphthalmia) in the developmental rabbit studies (at doses ≥400 mg/kg/day). Therefore, a separate acute dietary endpoint for females of reproductive age is not necessary. As discussed in this unit, EPA has reduced the Food Quality Protection Act (FQPA) Safety Factor (SF) to 1x, and thus the acute Population Adjusted Dose (aPAD) is equivalent to the acute Reference Dose (aRfD).

The chronic POD of 5.5 mg/kg/day was selected based on the NOAEL in a chronic toxicity/carcinogenicity feeding study in rats. The LOAEL in that study was 27.6 mg/kg/day based on decreased body weight and body weight gain in females; increased incidences of hepatocellular hypertrophy, pigment in centrilobular hepatocytes, eosinophilic foci of altered hepatocytes, vacuolation of centrilobular hepatocytes, bile duct hyperplasia, and bile duct fibrosis in both sexes; and brown pigment in the kidney in females. An uncertainty factor of 100x (10x to account for interspecies extrapolation and 10x for intraspecies variation) was applied to the dose to obtain the chronic reference dose (cRfD) of 0.055 mg/kg/day. As discussed in this unit, EPA has reduced the FQPA SF to 1x, and thus, the chronic population adjusted dose (cPAD) is equivalent to the cRfD.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isopyrazam, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from isopyrazam in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

A conservative acute dietary (food only) exposure analysis was performed for the general U.S. population and various population subgroups. Tolerance level residues and 100 percent crop treated (PCT) assumptions were used. Dietary Exposure Evaluation Model (DEEM) default processing factors were used for processed commodities, since separate tolerances are not considered necessary for processed banana commodities.

ii. Chronic exposure. Conservative chronic and cancer dietary (food only) exposure analyses were performed for the general U.S. population and various population subgroups. Tolerance level residues and 100 PCT assumptions were used. DEEM default and empirical processing factors were used for banana processed commodities, since separate tolerances for these commodities were not considered necessary.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. If quantitative cancer risk assessment is appropriate, cancer risk may be quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that isopyrazam should be classified as “Likely to be Carcinogenic to Humans”.

A linear quantification of carcinogenic potential was required for isopyrazam based on rat tumors. A cancer slope factor or Q1* of 0.00629 (mg/kg/day) −1 was calculated based on an increase in liver adenomas and/or carcinomas in female rats. The resulting cancer aggregate (food) exposure estimate was less than the level of concern. Cancer risk was 1.3 × 10−7 for the general U.S. population. Cancer risk was quantified using the same estimates as discussed in Unit III.C.1.ii.

2. Dietary exposure from drinking water. An assessment of residues in drinking water is not needed because there is no drinking water exposure associated with the establishment of a tolerance on imported crops.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Isopyrazam is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found isopyrazam to share a common mechanism of toxicity with any other substances, and isopyrazam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isopyrazam does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10x) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10x, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is some evidence for increased susceptibility following pre- and or postnatal exposures based on effects seen in range finding developmental toxicity studies in rabbits. Developmental effects (eye abnormalities) were observed in two preliminary developmental studies in Himalayan rabbits in the absence of maternal toxicity. These effects occurred at relatively high doses (200-400 mg/kg/day). There was no evidence of increased susceptibility in the main study in New Zealand white rabbits. In range finding and definitive developmental toxicity studies in rats, neither quantitative nor qualitative evidence of increased susceptibility of fetuses to in utero exposure to isopyrazam was observed. There was no evidence of increased susceptibility in a 2-generation reproduction study following pre- or postnatal exposure to isopyrazam. There is no evidence of neuropathology or abnormalities in the development of the fetal nervous system from the available toxicity studies conducted with isopyrazam. Clear NOAELs/LOAELs were established for the developmental effects seen in rats and rabbits as well as for the offspring effects seen in the 2-generation reproduction study and a dose-response relationship for the effects of concern is well characterized. The dose used for the acute dietary risk assessment (30 mg/kg/day), based on effects seen in the subchronic dog study, is protective of the developmental and offspring effects seen in rabbits at 200-400 mg/kg/day. Based on these considerations, there are no residual uncertainties for pre-and/or postnatal susceptibility.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings:

i. The toxicity database for isopyrazam is complete and adequate for assessing increased susceptibility under FQPA;

ii. There is no indication of increased susceptibility of fetuses to in utero and/or postnatal exposure in the developmental and reproductive toxicity studies in rats;

There is some evidence for increased susceptibility following pre- and or postnatal exposures based on effects seen in range finding developmental toxicity studies in rabbits. However, based on the discussion above, EPA has concluded that there are no residual uncertainties for pre-and/or postnatal susceptibility.

iii. The dietary risk assessment is based on parent plus metabolite residues in/on banana, and will not underestimate dietary exposure to isopyrazam. For the acute, chronic and cancer dietary analyses, tolerance level residues of parent plus metabolite and 100 PCT assumptions were used for all treated commodities. There are no residual uncertainties identified in the exposure databases.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate margin of exposure (MOE) exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to isopyrazam will occupy less than 1% of the aPAD for all populations.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isopyrazam from food will utilize less than 1% of the cPAD for all populations receiving the greatest exposure. There are no residential uses for isopyrazam.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Isopyrazam is not registered in the U.S. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for isopyrazam.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Isopyrazam is not registered in the U.S. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for isopyrazam.

5. Aggregate cancer risk for U.S. population. The Cancer Assessment Review Committee (CARC) classified isopyrazam as Likely to be Carcinogenic to Humans. This classification was based on the presence of thyroid follicular cell tumors in male rats, and liver and uterine tumors in female rats at doses that were adequate to evaluate the carcinogenic potential of isopyrazam. No treatment-related tumors were seen in mice. There is no mutagenic concern for isopyrazam.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to isopyrazam residues.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for isopyrazam on banana.

V. Conclusion

Therefore, a tolerance is established for residues of isopyrazam, in or on banana at 0.05 ppm.

VI. Statutory and Executive Order Reviews

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the national government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

VII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

PART 180—[AMENDED]1. The authority citation for part 180 continues to read as follows:Authority:

21 U.S.C. 321(q), 346a and 371.

2. Section 180.654 is added to read as follows:§ 180.654Isopyrazam; tolerances for residues.

(a) General. Tolerances are established for residues of the fungicide isopyrazam, including its metabolites and degradates, in or on the commodity listed below. Compliance with the tolerance levels specified below is to be determined by measuring only isopyrazam, 3-difluoromethyl-1-methyl-1H-pyrazole-4-carboxylic acid (9-isopropyl-1,2,3,4-tetrahydro-1,4-methano-naphthalen-5-yl)-amide, in or on the following commodity.

CommodityParts per millionBanana10.051 There is no U.S. registration for use of isopyrazam on banana.

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2011-25707 Filed 10-4-11; 8:45 am]BILLING CODE 6560-50-P DEPARTMENT OF TRANSPORTATIONOffice of the Secretary49 CFR Parts 18 and 19RIN 2105-AD60Grants and Cooperative Agreements to State and Local Governments: DOT Amendments on Regulations on Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals and Other Non-Profit OrganizationsAGENCY:

Department of Transportation (DOT), Office of the Secretary (OST).

ACTION:

Final rule.

SUMMARY:

The Department of Transportation (DOT) is adopting a public proposal on Grants and Cooperative Agreements to State and Local Governments; Grants and Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations. The rule amends Department of Transportation regulations on uniform administrative requirements for grants and agreements with Institutions of Higher Education, Hospitals and other Non-profit Organizations. Specifically, the DOT is making requirements for these grants and agreements consistent with the uniform administrative requirements for grants and cooperative agreements to State and Local governments. In addition, this rule updates references to applicable cost principles for grants and cooperative agreements with State and Local Governments that appear in current Department of Transportation regulations.

Regulations governing two types of U.S. Department of Transportation grant and cooperative agreements recipients are found in Parts 18 and 19 of Title 49 of the Code of Federal Regulations:

1. 49 CFR part 18: Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments.

2. 49 CFR part 19: Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations.

Both of these parts contain a provision that governs allowable costs. However, 49 CFR 18.22 imposes specific limitations on the use of grant funds while 49 CFR 19.27 merely lists cost principles applicable to each kind of grant and agreement recipient. Specifically, under 49 CFR 18.22(a), grant funds may only be used for:

(1) The allowable costs of the grantees, subgrantees and cost-type contractors, including allowable costs in the form of payments to fixed-price contractors; and

(2) Reasonable fees or profit to cost-type contractors but not any fee or profit (or other increment above allowable costs) to the grantee or subgrantee.

Public comments on this matter were solicited in a Federal Register notice dated May 2, 2008. Only one comment was received, from Robert Taylor, regarding the Office of Management and Budget (OMB) cost principle circulars as well as revisions prohibiting the payment of profit or fee to grantees and subgrantee covered by 49 CFR part 19. This comment did not pertain to the content of the proposed rule. Therefore, we are adopting the proposed rule without change.

This rule imposes the same limitation on the use of funds used for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations as there are on the use of funds used for Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments.

In addition, this rule updates references to applicable cost principles for grants and cooperative agreements with State and Local Governments that appear in 49 CFR 18.22(b) and include comparable updates references in 49 CFR 19.27(b). These updated references are necessary in light of the establishment of title 2 of the Code of Federal Regulations in 2004. Subtitle A of title 2 of the Code of Federal Regulations consists of government-wide guidance from the Office of Management and Budget (OMB) to Federal agencies for grants and other financial assistance and nonprocurement agreements that previously had been contained in seven separate OMB circulars and other OMB policy documents. Currently, 49 CFR 18.22(b) references three specific OMB circulars that are now codified in several Parts in chapter II, subtitle A of title 2 of the Code of Federal Regulations. This rule amends 49 CFR 18.22(b) by replacing the citations to these former OMB circulars with the appropriate references in title 2 of the Code of Federal Regulations and would reflect these same changes in 49 CFR 19.27(b).

The rule also makes minor referencing revisions to the Office of Management and Budget (OMB) cost principle circulars and, consistent with OMB materials, revises prohibitions on payment of profit or fee to grantees and subgrantees covered by 49 CFR part 19. The revised referencing is needed as the OMB cost circulars have been published in Title II of the Code of Federal Regulations since August 2005. However, these OMB circulars are only published as guidance (see 2 CFR 1.105(a)). Also, the OMB circular number has been retained in the title of each circular, for example, 2 CFR part 225, Cost Principles for State and Local Governments (OMB Circular A-87).

The title for the CFR part 19, which includes the OMB Circular number in the title, is included in the reference for all three cost principles. In addition, this makes the formatting of all titles in 49 CFR sections 18.22 and 18.27 consistent.

Rulemaking Analyses and NoticesExecutive Order 12866 (Regulatory Planning and Review) and DOT Regulatory Policies and Procedures

The DOT has determined that this document does not constitute a significant rule within the meaning of Executive Order 12866 or within the meaning of Department of Transportation regulatory policies and procedures. DOT anticipates that the economic impact of this rule will be minimal because the effect of the rule is simply to make similar provisions consistent with each other. These changes do not adversely affect, in a material way, any sector of the economy. In addition, the change does not interfere with any action taken or planned by another agency and does not materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs. Consequently, a full regulatory evaluation is not required.

Regulatory Flexibility Act

In compliance with the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 60l-612) the Department has evaluated the effects of this proposed action on small entities. This ruledoes not have any economic effects, let alone significant effects, on anyone. This rulemaking establishes the same limitation on the use of funds for both Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations and Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments. The amendment does not change or limit the potential eligibility of any small entity. For these reasons, the DOT certifies that this action would not have a significant economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

This rule does not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995, 109 Stat. 48). Indeed, it does not impose any mandates. This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year (2 U.S.C. 1532).

Executive Order 13132 (Federalism Assessment)

This rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, and the DOT has determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism assessment. The DOT has also determined that this rule does not preempt any State law or State regulation or affect the States' ability to discharge traditional State governmental functions.

Executive Order 12372 (Intergovernmental Review)

Catalog of Federal Domestic Assistance Program Number [Insert number], [Insert Program Name]. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities [apply/do not apply] to this program.

Paperwork Reduction Act

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et seq.), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct, sponsor, or require through regulations. The DOT has determined that this rule does not contain collection of information requirements for the purposes of the PRA.

National Environmental Policy Act

The agency has analyzed this rule for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321) and has determined that this rule does not have any effect on the quality of the environment.

For the costs of aUse the principles in—State, local or federal-recognized Indian tribal government2 CFR part 225.Private nonprofit organization other than an (1) Institution of higher education, (2) hospital, or (3) organization named in 2 CFR part 230, Appendix C, as not subject to that part2 CFR part 230.Institutions of Higher Education2 CFR part 220.For-profit organizations other than a hospital, commercial organization or a non-profit organization listed in 2 CFR part 230, Appendix C, as not subject to that part48 CFR part 31. Contract Cost Principles and Procedures, or uniform cost accounting standards that comply with cost principles acceptable to the Federal agency.PART 19—UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS3. The authority citation for 49 CFR part 19 continues to read as follows:Authority:

49 U.S.C. 322(a).

4. Revise § 19.27 to read as follows:§ 19.27 Allowable Costs.

(a) Limitation on use of funds. Grant funds may be used only for:

(1) The allowable costs of the grantees, subgrantees and cost-type contractors, including allowable costs in the form of payments to fixed-price contractors; and

(2) Reasonable fees or profit to cost-type contractors but not any fee or profit (or other increment above allowable costs) to the grantee or subgrantee.

(b) Applicable cost principles. For each kind of recipient, there is a set of Federal principles for determining allowable costs. Allowability of costs shall be determined according to the cost principles applicable to the entity organization incurring the costs. The following chart lists the kinds of organization and the applicable cost principles:

For the costs of aUse the principles in—State, local or federal-recognized Indian tribal government2 CFR part 225.Private nonprofit organization other than an (1) Institution of higher education, (2) hospital, or (3) organization named in 2 CFR part 230, Appendix C, as not subject to that circular2 CFR part 230.Institutions of Higher Education2 CFR part 220.Hospitals45 CFR part 74, Appendix E, “Principles for Determining Costs Applicable to Research and Development under Grants and Contracts with Hospitals.”For-profit organizations other than a hospital, commercial organization or a non-profit organization listed in 2 CFR part 230, Appendix C, as not subject to that part48 CFR part 31. Contract Cost Principles and Procedures, or uniform cost accounting standards that comply with cost principles acceptable to the Federal agency.[FR Doc. 2011-25416 Filed 10-4-11; 8:45 am]BILLING CODE 4910-9X-PDEPARTMENT OF THE INTERIORFish and Wildlife Service50 CFR Part 17[FWS-R1-ES-2008-0079; 92210-1117-0000-FY08-B4]RIN 1018-AW84Endangered and Threatened Wildlife and Plants; Revised Critical Habitat for the Marbled MurreletAGENCY:

Fish and Wildlife Service, Interior.

ACTION:

Final rule.

SUMMARY:

We, the U.S. Fish and Wildlife Service (Service), are revising designated critical habitat for marbled murrelet (Brachyramphus marmoratus marmoratus) pursuant to the Endangered Species Act of 1973, as amended (Act). On May 24, 1996, we designated 3,887,800 ac (ac) (1,573,340 hectares (ha)) as critical habitat for the marbled murrelet in Washington, Oregon, and California. We are revising the designated critical habitat for the marbled murrelet by removing approximately 189,671 ac (76,757 ha) in northern California and southern Oregon from the 1996 designation, based on new information indicating that these areas do not meet the definition of critical habitat. The areas being removed from the 1996 designation in northern California are within Inland Zone 2, where we have no historical or current survey records documenting marbled murrelet presence. Intensive surveys in southern Oregon indicate the inland distribution of the marbled murrelet is strongly associated with the hemlock/tanoak habitat zone, rather than distance from the coast. Accordingly, the areas being removed in southern Oregon are limited to those areas not associated with the hemlock/tanoak zone. The areas being removed are not considered essential for the conservation of the species. Approximately 3,698,100 ac (1,497,000 ha) of critical habitat is now designated for the marbled murrelet. In this rule, we are also finalizing the taxonomic revision of the scientific name of the marbled murrelet from Brachyramphus marmoratus marmoratus to Brachyramphus marmoratus.

DATES:

This rule becomes effective on November 4, 2011.

ADDRESSES:

The final rule and map of critical habitat will be available on the Internet at http://www.regulations.gov and http://www.fws.gov/wafwo/. Comments and materials received, as well as supporting documentation used in the preparation of this final rule, are available at http://www.regulations.gov or for public inspection, by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Washington Fish and Wildlife Office, 510 Desmond Drive SE, Suite 102, Lacey, WA 98503-1273, telephone 360-753-9440, facsimile 360-753-9008.

A final rule designating critical habitat for the marbled murrelet was published in the Federal Register on May 24, 1996 (61 FR 26256), and is available under the “Supporting Documents” section for this docket in the Federal eRulemaking Portal: http://www.regulations.gov at Docket Number FWS-R1-ES-2008-0079. It is our intent to discuss only those topics directly relevant to the revised designation of critical habitat for the marbled murrelet in this final rule.

Species Description, Life History, Distribution, Ecology, and Habitat

The marbled murrelet is a small seabird of the Alcidae family. The marbled murrelet's breeding range extends from Bristol Bay, Alaska, south to the Aleutian Archipelago; northeast to Cook Inlet, Kodiak Island, Kenai Peninsula, and Prince William Sound; south along the coast through the Alexander Archipelago of Alaska, British Columbia, Washington, and Oregon; to northern Monterey Bay in central California. Birds winter throughout the breeding range and occur in small numbers off southern California. Marbled murrelets spend most of their lives in the marine environment where they forage in near-shore areas and consume a diversity of prey species, including small fish and invertebrates. In their terrestrial environment, the presence of platforms (large branches or deformities) used for nesting in trees is the most important characteristic of their nesting habitat. Marbled murrelet habitat use during the breeding season is positively associated with the presence and abundance of mature and old-growth forests, large core areas of old-growth, low amounts of edge habitat, reduced habitat fragmentation, proximity to the marine environment, and forests that are increasing in stand age and height.

Taxonomy

Two subspecies of the marbled murrelet were previously recognized, the North American murrelet (Brachyramphus marmoratus marmoratus) and the Asiatic murrelet (B. marmoratus perdix). New published information suggests that the Asiatic murrelet is a distinct species (Friesen et al. 1996, 2005), and the American Ornithologists' Union officially recognized the long-billed murrelet (B. perdix) and the marbled murrelet (B. marmoratus) as distinct species in the “Forty-first Supplement to the Checklist of North American Birds” (American Ornithologists' Union 1997). Therefore, in this rule we are revising 50 CFR 17.11 to adopt the taxonomic clarification for the marbled murrelet to reflect the change from Brachyramphus marmoratus marmoratus to Brachyramphus marmoratus.

Previous Federal Actions

For additional information on previous Federal actions concerning the marbled murrelet, refer to the final listing rule published in the Federal Register on October 1, 1992 (57 FR 45328), the final rule designating critical habitat published in the Federal Register on May 24, 1996 (61 FR 26256), and the proposed rule published in the Federal Register on July 31, 2008 (73 FR 44678). In the 1996 final critical habitat rule, we designated 3,887,800 ac (1,573,340 ha) of critical habitat in 32 units on Federal and non-Federal lands. On September 24, 1997, we completed a Recovery Plan for the marbled murrelet in Washington, Oregon, and California (Service 1997). On January 13, 2003, we entered into a settlement agreement with the American Forest Resource Council and the Western Council of Industrial Workers, whereby we agreed to review the marbled murrelet critical habitat designation and make any revisions deemed appropriate after a revised consideration of economic and any other relevant impacts of designation. On April 21, 2003, we published a notice initiating a 5-year review of the marbled murrelet (68 FR 19569), and published a second information request for the 5-year review on July 25, 2003 (68 FR 44093). The 5-year review evaluation report was finished in March 2004 (McShane et al. 2004), and the 5-year review was completed on August 31, 2004.

On September 12, 2006, we published a proposed revision to critical habitat for the marbled murrelet, which included adjustments to the original designation and proposed several exclusions under section 4(b)(2) of the Act (71 FR 53838). On June 26, 2007, we published a notice of availability of a draft economic analysis (72 FR 35025) related to the September 12, 2006, proposed critical habitat revision (71 FR 53838). On March 6, 2008, we published a notice in the Federal Register (73 FR 12067) stating that the critical habitat for marbled murrelet should not be revised due to uncertainties regarding Bureau of Land Management (BLM) revisions to its District Resource Management Plans in western Oregon, and this notice fulfilled our obligations under the settlement agreement.

On July 31, 2008, we published a proposed rule to revise currently designated critical habitat for the marbled murrelet by removing approximately 254,070 acres (ac) (102,820 hectares (ha)) in northern California and Oregon from the 1996 designation (73 FR 44678). A revised 5-year review was completed on June 12, 2009. On January 21, 2010, in response to a petition to delist the marbled murrelet, we published a notice in the Federal Register (75 FR 3424) determining that removing the murrelet from the Endangered Species List was not warranted. We also found that the Washington/Oregon/California population of the murrelet is a valid distinct population segment (DPS) in accordance with the discreteness and significance criteria in our 1996 DPS policy (61 FR 4722; February 7, 1996) and concluded that the species continues to meet the definition of a threatened species under the ESA.

Summary of Comments and Recommendations

We requested written comments from the public on the proposed revised designation of critical habitat for the marbled murrelet in a proposed rule published on July 31, 2008 (73 FR 44678). During the comment period, which closed on August 30, 2008, we received 42 comments from organizations or individuals directly addressing the proposed critical habitat designation. Through template campaigns sponsored by The Wildlife Society and Conservation Northwest, we received an additional 2,825 comments.

The comment period was reopened on February 11, 2009 (74 FR 6852), and closed on March 13, 2009, during which we received 14 comments, which included 4 peer reviewers, 1 Federal agency, and 9 organizations or individuals. Nearly all commenters opposed the revision or reduction of some aspects of the designation of critical habitat for the marbled murrelet.

Several comments we received were outside the scope of the proposed rule, which was limited to (1) The proposed removal of approximately 191,000 ac (77,295 ha) of critical habitat in northern California and southern Oregon based on the very low likelihood of marbled murrelet occurrence as is discussed in further detail below; (2) the proposed removal of approximately 63,000 ac (25,495 ha) of critical habitat in Douglas and Lane Counties, Oregon, that were designated farther than 35 miles inland, based on criteria identified in the 1997 Recovery Plan for the Marbled Murrelet (Washington, Oregon, and California Populations); and (3) the proposed taxonomic revision of the scientific name of the marbled murrelet. Examples of comments outside of the scope of the proposed rule included:

(a) Requests that we remove approximately 1,840 ac (744.6 ha) of existing critical habitat designated at Naval Radio Station Jim Creek in Washington pursuant to section 4(a)(3)(B)(i) of the Act;

(f) Recommendations to exclude critical habitat from all Federal lands including Wilderness areas and Congressionally withdrawn lands in general based on the conservation adequacy of existing management plans;

(g) Requests for the exclusion of Federal lands in northern California based on approved management plans;

(h) Requests that we eliminate overlapping protections for Wilderness Designations and Congressional Withdrawal areas in northern California; and

(i) Requests that we update land status records related to critical habitat boundaries.

These comments are beyond the scope of the proposed rule, and some would require separate rulemaking to be considered. Accordingly, we have not specifically responded to these comments in this final rule.

Comments within the scope of the proposed rule have been addressed in the following summary and have been incorporated into the final rule as appropriate. We did not receive any requests for a public hearing.

Peer Review

In accordance with our policy published in the Federal Register on July 1, 1994, (59 FR 34270), we solicited opinions from nine knowledgeable individuals with scientific expertise that included familiarity with the species, the geographic region in which the species occurs, and conservation biology principles. We received responses from four of the peer reviewers who were solicited. We reviewed all comments received from the peer reviewers for substantive issues and new information regarding murrelet critical habitat. We have addressed peer review comments in the following summary and have incorporated them into this final rule as appropriate.

Several comments refer to inland zone 1 and inland zone 2, which are based on the Forest Ecosystem Management Assessment Team (FEMAT) murrelet zone lines. For clarification, inland zone 1 extends 10-40 miles (mi) (16-64 kilometers (km)) inland from the marine environment, depending on the particular geographic area involved. The majority of murrelet occupied sites and sightings occur in this zone. Inland zone 2 includes areas further inland from the eastern boundary of inland zone 1, and is characterized by relatively low numbers of murrelet sightings, which is partially a function of few inventories. Specific distances for inland zone 2 vary by geographic area (Thomas et al. 1993 (FEMAT), pp. IV-23-24).

Peer Reviewer Comments

Comment 1: Each of the four peer reviewers concurred with the proposed reclassification of the marbled murrelet to full species status. They stated the reclassification of the marbled murrelet to full species status is supported by the literature, and that the American Ornithologists' Union (the authoritative source for taxonomy and nomenclature of birds in North America) recognizes the marbled murrelet as a distinct species.

Our Response: We agree and note there is no disagreement in the literature or by the experts on the reclassification of marbled murrelet to full species status. We are finalizing the taxonomic revision of the scientific name of the marbled murrelet from Brachyramphus marmoratus marmoratus to Brachyramphus marmoratus in this rule.

Comment 2: One reviewer stated that the surveys used to determine occupancy in the areas proposed for revision were conducted under earlier survey protocols requiring fewer visits than the currently recognized protocol (Mack et al. 2003, pp. 12-16). Accordingly, the results contain a level of uncertainty that, although not egregious, should be recognized before a final decision is made. In areas of low detections it is difficult for audio/visual surveys to detect single birds, whereas the current protocol may have detected additional murrelets.

Our Response: The 2003 Marbled Murrelet Inland Survey Protocol (Mack et al. 2003) recommends five survey visits in each of 2 years to determine occupancy with an 85.3 percent probability of detecting occupancy in a given year. The 2-year intensive survey protocol accounts for years where breeding effort is low, resulting in fewer or no detections in otherwise occupied stands (Mack et al. 2003, p. 13). The probability of detecting occupancy decreases from 85.3 percent to 79.2 percent in any given year when conducting one less site visit per year, which increases the level of uncertainty associated with the survey results by approximately 6.1 percent (Mack et al. 2003, p.13). The studies we relied on in the areas proposed for revision in California, Hunter et al. (1998) and Schmidt et al. (2000), reported on surveys conducted across large landscapes in northern California's inland zone 2, using the Ralph et al. (1994) murrelet survey protocol. This protocol recommended only four survey visits in each of 2 years to determine occupancy. We acknowledge the studies we relied on used a survey protocol requiring fewer visits than is the current standard. However, given the large combined number of surveys (2,218) conducted in these studies, the additional/associated project-level surveys that have occurred since with no detections, the absence of historical records of murrelet presence in inland zone 2 in California based on U.S. Forest Service (USFS) and BLM records, and the apparent climatic differences between inland zone 2 areas and the closest known occupied murrelet sites within inland zone 1, we conclude from the best available scientific information that there is a very low likelihood of murrelet occupancy within inland zone 2 in California.

In southern Oregon, Federal agencies undertook a comparable evaluation of the probability of marbled murrelet inland habitat use as forest types shift from the hemlock/tanoak vegetation zone to the mixed-conifer/evergreen vegetation zone (Alegria et al. 2002, pp. 1-44). This evaluation was based on survey results from the Medford District BLM, and the Siskiyou and Rogue River National Forests from 1988 to 2001 that documented the inland distribution of marbled murrelets to be strongly associated with the hemlock/tanoak habitat zone, which ranges from 13 to 37 mi (20.9 to 59.5 km) inland from the Pacific Ocean. The distribution of survey sites with murrelet presence or occupancy occur farther inland where the hemlock/tanoak zone extends farther inland, which suggests that forest type influences murrelet occurrence, rather than absolute distance from the coast (Alegria et al. 2002, p. 15).

For the purposes of the analysis, marbled murrelet survey areas were categorized as western hemlock-tanoak (the primary range of the marbled murrelet), a 6.5-mile transition zone east of the primary range, and the far inland zones. The statistical modeling evaluated the hypothesis that marbled murrelets would be present on no more than 3 percent (95 percent confidence) of the habitat in the far inland zones. The final analyses concluded, with 95 percent confidence, that an even smaller proportion (1.2 percent) of the landscape may have murrelet presence that was not actually detected. The analysis of 9,795 survey visits suggests that murrelets are not present in more than 98 percent of the sampled units in the far inland zones (Alegria et al., 2002, pp. 13-15). Only one distant auditory detection in 4,634 survey visits occurred within the area more than 6.5 mi (10.4 km) inland of the hemlock/tanoak vegetation type (Alegria et al., 2002, p. 16). Accordingly, our interpretation of the most recent data supports a determination that, in southern Oregon, murrelet use is strongly associated with tanoak/hemlock forest, rather than a 35 miles (56 kilometers) distance from the Pacific Ocean. The 35-mile (56-km) distance identified in the 1997 Marbled Murrelet Recovery Plan was based on the best available information before the Service at that time. Therefore, based on the best available scientific information, we conclude that there is a very low likelihood of murrelet occurrence in the area we are removing from critical habitat designation in southern Oregon, and, accordingly, impacts to the species in this area would be negligible.

Comment 3: One reviewer asked if radar studies were conducted and if so, suggested that we document the results.

Our Response: We are unaware of any ornithological radar surveys conducted in or near the areas proposed for revision in Oregon. In California, Schmidt et al. (2000), used ornithological radar instruments to survey for murrelets at three sites beyond their study area where murrelets had been previously detected far inland. These sites include Onion Mountain and Notice Creek within the eastern portion of inland zone 1, and Indian Creek within inland zone 2. However, murrelets were detected only at the Notice Creek site using this method. Previous audio-visual detections at Indian Creek have not been validated using either audio-visual surveys or ornithological radar. Cooper and Blaha (2005, 2006) used ornithological radar to survey five sites along Pine Creek on the western boundary of the Hoopa Valley Indian Reservation in California (inland zone 1), to confirm murrelet presence that had been documented in previous audio-visual surveys. Marbled murrelets were detected at two of the sites, approximately 7 miles west of the inland zone 2 boundary. Although the number of ornithological radar surveys in California in or near inland zone 2 is limited, the available data are consistent with the results of other surveys. Those surveys failed to detect murrelet presence within inland zone 2 or the easternmost portion of inland zone 1.

Comment 4: Two of the four reviewers who commented on the proposed removal of critical habitat in Douglas and Lane Counties in Oregon considered the rationale behind the revisions to be unsupported by the literature or information presented in the proposed rule. One reviewer suggested that a more thorough analysis of existing surveys be conducted before revising the inland boundary of critical habitat in these areas. Another reviewer requested more documentation that a majority of occupied sites occur within inland zone 1, and recommended that the critical habitat designation in Douglas and Lane Counties in Oregon not be revised until all of the existing data are thoroughly analyzed and additional systematic surveys have been conducted.

Our Response: Based on peer review and public comments, we have concluded that the proposed revision of critical habitat in Douglas and Lane Counties, Oregon, is not adequately supported by the literature and that currently available scientific information is inadequate to support a revision of critical habitat in this area. Accordingly, critical habitat in Lane and Douglas Counties, Oregon, remains designated as critical habitat, based on the best available scientific information.

Comment 5: One peer reviewer questioned whether the areas proposed for removal are within or outside of the currently occupied area, and stated that the failure to detect murrelets does not mean that they do not use an area, given the difficulty of surveying this secretive species.

Our Response: See response to peer reviewer Comment 2. Based on the detailed statistical analysis of the survey data, and the similarity of the areas not surveyed to the areas surveyed immediately to the north and south, there is low likelihood that murrelets occupy the areas proposed for removal from critical habitat designation in southern Oregon and northern California.

Comment 6: One reviewer pointed out that the habitat proposed for removal from critical habitat designation may act as a buffer of sorts for currently occupied habitat, particularly where it abuts the eastern edge of obviously occupied habitat. Increases in timber harvest or recreation in these areas would potentially bring edge effects (especially increased numbers of nest predators) closer to occupied habitat, and may reduce the suitability of the currently occupied habitat. The reviewer stated that maintenance of a buffer is essential to the conservation of murrelets in currently occupied habitat.

Our Response: In northern California, critical habitat remains designated over an area that ranges from 15 mi (24 km) to 20 mi (32 km) wide, between the west side of inland zone 1 within the redwood vegetation type (which contains more than 95 percent of the known occupied murrelet sites), and the revised eastern boundary of inland zone 1 within the Douglas-fir/tanoak vegetation type. In southern Oregon, critical habitat remains designated within a 6.5-mi-wide (10.5-km-wide) area between large amounts of known occupied murrelet habitat within the hemlock/tanoak vegetation type west of inland zone 1, and the break in vegetation to the mixed-conifer/evergreen vegetation type to the east. On a large landscape scale, these areas are generally managed to protect the PCEs of murrelet critical habitat (see Primary Constituent Elements below), although they have not been intensively surveyed. As a result, there is a significant distance between the eastern-most known occupied murrelet sites and the areas being removed from critical habitat designation in northern California and southern Oregon. These areas, while not “buffers,” may help maintain the suitability of known nesting habitat by decreasing the potential for indirect impacts related to timber harvest activities or increased predation.

Comment 7: One reviewer stated that it is essential to conserve a wide range of habitat to increase the chances that a species will be able to adapt to dynamic changes in the habitat. In his view, the areas proposed for removal from critical habitat represent small and large habitat remnants that may provide future refuges from warm temperatures, violent coastal storms, disease, invasive competitive species or predators, or extensive fire. He stated that both large and small fragments of mature, structurally complex forest located away from human activity may provide useful nesting habitat that is essential to conservation.

Our Response: On May 24, 1996, we designated 3,887,800 ac (1,573.340 ha) of critical habitat on Federal and non-Federal lands in Washington, Oregon, and California (61 FR 26256). While this revision will remove approximately 189,671 acres (76,760 ha) from the designation in Oregon and California, it only affects areas that are not essential to the conservation of the species based on the best scientific information available (see response to peer review comment 2). Accordingly, we do not believe the areas that are being removed would provide future nesting habitat, refuges from warm temperatures, violent coastal storms, disease, invasive competitive species or predators, or extensive fire, since these areas are not likely to be used by murrelets. The remaining critical habitat designation encompasses a wide range of habitat distributed throughout the range of the marbled murrelet from the Canadian border through California, and inland from the coast, which represents large and small fragments of mature, structurally complex forest that are located away from human disturbance.

Comment 8: One reviewer noted that, if critical habitat designation is removed, it is likely the areas affected will be harvested for timber or receive greater recreational use, either of which will reduce the suitability as nesting habitat. Another reviewer commented that there is a strong correlation between murrelet population size and the amount of nesting habitat adjacent to the birds, and there is reason to believe that further loss of adjacent habitat could result in population decline.

Our Response: The critical habitat areas being removed in southern Oregon and northern California are outside of known nesting habitat, not likely to be occupied by murrelets, and not essential to the conservation of the species (see response to Peer Review Comment 2).

Comment 9: One reviewer commented that there appeared to be little reason to revise the critical habitat designation, which in the reviewer's view would limit the conservation options for murrelets. The reviewer noted that the proposal did not articulate any economic or security issues, and suggested that, in uncertain times, it is prudent to be conservative and “hedge your bets when the consequences of loss are high, especially when the costs are low.”

Our Response: We disagree that future conservation options will be limited by this revision. Marbled murrelets remain protected as a listed species wherever they occur, regardless of a critical habitat designation. Federal agencies have an independent responsibility under section 7(a)(1) of the Act to use their authorities to carry out programs for the conservation of endangered and threatened species, and a requirement under section 7(a)(2) of the Act to ensure that their actions do not jeopardize listed species. The take of listed species is prohibited by section 9 of the Act without a permit under sections 10(a)(1)(A) or 10(a)(1)(B) of the Act, or an incidental take statement under section 7(b)(4)(C) of the Act.

The Marbled Murrelet Recovery Plan states that recovery actions in southern Oregon and northern California should be focused on preventing the loss of occupied nesting habitat, minimizing the loss of unoccupied but suitable habitat, and decreasing the time for development of new suitable habitat (Service 1997, p. 128). Recovery task 4.1.4 in the Recovery Plan states: (1) A definition of suitable marbled murrelet habitat should be developed for each Conservation Zone to better determine and map appropriate areas for murrelet recovery; (2) the components of suitable marbled murrelet habitat are generally known but a description of suitable marbled murrelet habitat for each zone is lacking; and (3) once definitions are developed, mapping marbled murrelet habitat can be accomplished with greater accuracy (Service 1997, p. 149). Recovery task 4.1.6 states that intensive surveys should be conducted to identify nesting areas and delineate the inland boundary of nesting habitat (Service 1997, p. 150).

Intensive surveys to determine murrelet presence in southern Oregon indicate that the inland distribution of marbled murrelets is strongly associated with the hemlock/tanoak habitat zone, and not the distance from the coast. This is probably due to the maritime climate that provides milder, wetter conditions that favor development of larger trees and more abundant moss cover. The hemlock/tanoak zone transitions relatively rapidly to the mixed-conifer/mixed-evergreen zone that has hotter, drier climate. This rapid transition to less favorable conditions for murrelets may explain why they aren't detected beyond the hemlock/tanoak vegetation zone (Alegria et al., 2002, pp. 15-16).

There are no historical or current survey records documenting murrelet presence in inland zone 2 in California (Hunter et al., 1998; Schmidt et al., 2000). Studies conducted by Hunter et al. (1997, p. 20), indicate that the northern Inner North Coast Ranges of California are not within the current range of the marbled murrelet, which could be influenced by several factors, including habitat structure, elevation, predator abundance, distance inland, and climatic conditions. Daily maximum summer temperatures were significantly higher within the zone 2 study area than at inland sites documented with murrelets closer to the coast (Hunter et al., 1998); summer temperature is often inversely correlated with humidity and cloud cover (Anthes et al., 1975); in California, the vast majority of murrelet records are from redwood-dominated stands (E. Burkett, pers. com); and the historical inland extent of redwood forests in California closely matches the inland extent of marine air influences and summer fog (Major 1977) (in Schmidt et al., 2000, pp. 21-22). This evidence, combined with the distance from the closest known occupied murrelet sites within inland zone 1 (9 mi (14 km) west and 15 mi (25 km) west; Schmidt et al. 2000, p. 11; Hunter et al., 1997, p. 7) indicates a very low likelihood of murrelet occupancy within inland zone 2 in California. Accordingly, the areas designated as critical habitat in 1996 in southern Oregon that are not within the hemlock/tanoak habitat zone, and the areas within inland zone 2 in California, are not considered suitable habitat for marbled murrelet recovery.

The biological criteria used to identify critical habitat in the final rule (61 FR 26265; May 24, 1996) include suitable nesting habitat, survey data, proximity to marine foraging habitat, large contiguous blocks of nesting habitat, and rangewide distribution. Based on the best available information, there is no biological rationale to support retaining marbled murrelet critical habitat in areas that are neither presently used (i.e., unoccupied), nor likely to be used in the future by the species (i.e., unsuitable). Consequently, we believe the removal of critical habitat from areas that are not essential to the conservation of the species in southern Oregon and northern California is appropriate. Removing critical habitat from these areas will allow Federal agencies to focus their conservation efforts on the areas that currently provide murrelet habitat and have a greater likelihood of providing habitat into the future. The designation of critical habitat in Douglas and Lane Counties in Oregon is not affected by this revision, and these lands will continue to provide a conservation benefit to the species.

Public Comments

Comment 10: Commenters stated the murrelet recovery plan identifies the Northwest Forest Plan (NWFP) reserves as the backbone of the recovery effort, but Late-Successional Reserves (LSRs) are administrative designations that can be removed. In addition, the Evaluation Report for the 5-Year Status Review for the Marbled Murrelet (McShane et al., 2004; p 4-76) indicates there are problems with placing too much reliance on the NWFP. Commenters also stated that if the NWFP remains in effect and is not altered substantially from its current form, the projected acreage of USFS and BLM lands in the Pacific Northwest that support stands older than 200 years (200 years defines the lower limit of old-growth forest) is expected to increase substantially by the year 2050. They also commented that the Recovery Plan for the Marbled Murrelet states “it will take 50 to 100 years or more to develop new suitable nesting habitat within most reserve areas,” however, the NWFP is being dismantled before it has had a chance to succeed. Other commenters stated that the LSRs need critical habitat designation to ensure they are managed for long-term recovery of the species.

Our Response: Based on the best available scientific information related to survey data, there is a very low likelihood that murrelets occupy the areas being removed from critical habitat designation in southern Oregon and northern California (see responses under Peer Reviewer Comments above). The areas being removed are no longer considered suitable habitat. Accordingly, these areas are not essential to the conservation of the species, and murrelet recovery would not be affected by the management of these specific areas. This revision of critical habitat will help Federal agencies focus their conservation efforts on the areas that currently provide habitat for murrelets, and areas that have a greater likelihood of providing habitat into the future. Based on the best available scientific information, the areas that were designated as critical habitat in Lane and Douglas Counties, Oregon, in 1996 have been determined to contain the physical or biological features essential to the conservation of the species and are not being revised.

Comment 11: One commenter stated that the Service must present a balanced economic analysis, including benefits of old-growth habitat conservation and restoration, and that an economic analysis must be prepared if BLM lands are designated in order to address consequences to communities and counties.

Our Response: Section 4(b)(2) of the Act requires that the Service consider economic impacts when “specifying any particular area as critical habitat.” Characterizing the potential economic benefits of critical habitat designation can provide context to the potential economic cost estimates, where that information is available. However, since this final rule removes critical habitat that was previously “specified,” and we are not removing these areas under Section 4(b)(2) on economic grounds, we have determined that a new economic analysis is not required.

Comment 12: Some commenters stated that the proposal to revise critical habitat should be withdrawn and replaced with a delisting proposal, and the Service should not designate critical habitat for a species that no longer warrants ESA protection.

Our Response: We disagree. The marbled murrelet DPS in Washington, Oregon, and California continues to warrant protection under the Act, for the reasons described in the 12-month Finding on a Petition to Remove the Marbled Murrelet from the List of Endangered and Threatened Wildlife, published in the Federal Register on January 21, 2010 (75 FR 3424). That finding determined that the DPS continues to meet the definition of a threatened species based on the species' population size and trajectory, in light of the scope and magnitude of existing threats.

Comment 13: Commenters stated there is no need to modify critical habitat in areas that are currently designated as LSRs, and there is little or no incremental cost to conserve marbled murrelet critical habitat in LSRs and riparian reserves, because these areas are already established for the purpose of conserving late successional wildlife.

Our Response: Section 3(5)(A) of the Act defines critical habitat as (1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with section 4 of this Act, on which are found those physical or biological features (a) Essential to the conservation of the species, and (b) which may require special management considerations or protection; and (2) specific areas outside the geographical area occupied by the species at the time it is listed in accordance with the provisions of section 4 of the Act, upon a determination that such areas are essential for the conservation of the species. The survey data for southern Oregon and northern California, along with the quality and quantity of habitat in this area, indicate there is a very low likelihood that murrelets occupy the LSRs or the other areas being removed from the 1996 critical habitat designation, and are unlikely to occupy these areas in the future (see responses under Peer Reviewer Comments). Accordingly, based on the best available scientific information, we have determined that these areas are not essential to the conservation of the species; therefore, requiring Federal agencies to enter into section 7 consultation with the Service on effects to critical habitat in these areas would be inconsistent with the Act. However, critical habitat in Lane and Douglas Counties, Oregon, will remain as designated in 1996, since those areas are occupied and essential to the conservation of the species.

Federal Agency Comments

Comment 14: The BLM suggested (a) Adding language to the final rule that clearly articulates that the PCEs must be present on the lands within the mapped critical habitat units for the area to meet the statutory definition of critical habitat; (b) that the final rule clarify that activities proposed to occur on lands that do not contain PCEs within the mapped critical habitat units will not be subject to a destruction or adverse modification determination because such lands, by definition, are not critical habitat; and that (c) the proposed rule provide better guidance in regard to the functionality of forest stands in support of a critical habitat designation, particularly as related to the issue of fragmentation. BLM also expressed a concern that outdated land status information was used to prepare the proposed rule in northern California. They indicated that this is problematic in two key areas: Lacks Creek west of and adjacent to the Hoopa Reservation; and Gilman Butte east of the King Range National Conservation Area and south of Humboldt Redwoods State Park. The BLM also requested that we remove critical habitat from all areas not in the western hemlock/tanoak vegetation on the Grants Pass and Glendale Resource Areas of the Medford District. The agency commented that this area lacks murrelet recovery habitat, and historical observations and recent protocol surveys have not documented murrelet occupancy. The areas described include the southeasternmost 2 square miles of CHU OR-07-g, and the northeasternmost 24 square miles of CHU OR-07-f.

Our Response: (a) Areas outside of the geographical area occupied by a species at the time it is listed under the Act (i.e., unoccupied habitat) can be designated as critical habitat if the areas are essential to the conservation of the species; unoccupied areas considered essential may not necessarily contain the PCEs of physical or biological features. However, for the marbled murrelet, each of the areas designated as critical habitat is within the geographical area occupied by the species at the time it was listed under the Act, and contains those physical or biological features essential to the conservation of the species, which may require special management considerations or protection. Accordingly, each of the areas delineated and mapped in this final rule meet the definition of critical habitat.

(b) The marbled murrelet PCEs include individual trees with potential nest platforms and forest lands of at least one half site-potential tree height regardless of contiguity, within 0.8 km (0.5 mi) of individual trees with potential nesting platforms and that are used or potentially used by the marbled murrelet for nesting or breeding. Activities that occur within or adjacent to lands designated as critical habitat may still have an effect on PCEs, depending on the particular aspects of the Federal action involved. The preamble to the 1996 final critical habitat rule (61 FR 26265; May 24, 1996), states that “within the boundaries of designated critical habitat, only those areas that contain one or more primary constituent elements are, by definition, critical habitat. Areas without any primary constituent elements are excluded by definition.” However, this language is not in the final critical habitat rule itself and is no longer accurate. The potential effects of Federal actions that may affect any area within the boundaries of designated critical habitat will need to be evaluated on a project-specific basis during the section 7(a)(2) consultation process.

(c) The removal, modification, or fragmentation of forested areas can directly impact nesting structures, nesting substrate, and the vertical and horizontal cover provided by the surrounding forest. Fragmentation of forested areas can result in habitat isolation and increased edge, which can negatively impact the quality of the remaining nesting habitat primarily through increased predation, modification of the microclimate, and potential windthrow of nest trees. Examples of Federal actions that may affect marbled murrelet nesting habitat include timber harvest, salvage logging, hazard tree removal, road construction, recreational or other developments, fuels reduction projects, and indirect harvest-related effects such as windthrow. The key factor related to an adverse modification determination is whether, with implementation of a proposed Federal action, the affected critical habitat would continue to serve its intended conservation role for the species, or retain those physical or biological features that relate to the ability of the area to periodically support the species. The role of critical habitat is to support the life-history needs of the species and provide for conservation. Activities that may destroy or adversely modify critical habitat are those that would alter the physical or biological features to an extent that appreciably reduces the conservation value of critical habitat for the marbled murrelet.

The areas referred to by BLM within CHU OR-07-g and CHU OR-07-f occur within the 6.5-mile area designed to support murrelets that might use the area between the western hemlock/tanoak and mixed-conifer/evergreen vegetation zones. These areas were not considered for removal because of their proximity to occupied habitat (see response to Comment 6 under Peer Reviewer Comments).

Comments From States

We did not receive any comments from any State in response to the proposed rule.

Summary of Changes From the Proposed Rule

In preparing this final rule, we reviewed and fully considered comments from the public and peer reviewers that we received in response to the proposed rule published in the Federal Register on July 31, 2008 (73 FR 44678).

Based on the comments received, we have determined that the proposed removal of 63,000 ac (25,495 ha) of critical habitat designated in Douglas and Lane Counties in Oregon is not supported by the best available scientific information and would not be appropriate. Based on the best available scientific information, these areas contain the physical or biological features essential to the conservation of the species, and will continue to be designated as critical habitat. Therefore, we have removed instructions to remove the following critical habitat units from this final rule: OR-03-c, OR-03-e, OR-04-f, OR-04-g, OR-04-i, OR-04-j, and OR-06-d.

Systematic surveys such as those conducted by Hunter et al. (1998), Schmidt et al. (2000), and Alegria et al. (2002) were not conducted in a relatively small area (approximately 71,000 ac) in northern California located between the Klamath River and the Oregon border, and between the much larger areas surveyed by Hunter et al. (1998), Schmidt et al. (2000), and Alegria et al. (2002). However, based on the similarity of mixed-conifer habitat surveyed to the north and south, the lack of detections from the areas immediately north and south, and the lack of historical detections, we believe there is a very low likelihood that murrelets occur within inland zone 2 and the far eastern portions of inland zone 1 located between the Klamath River and the Oregon border in northern California. In light of what the current data indicate regarding the forest types that murrelets use for nesting (see response to Comment 9), we conclude that it is unlikely that murrelets will occupy these areas in the future. Accordingly, we have revised the critical habitat boundary in this area.

The critical habitat revision in southern Oregon and northern California is appropriate, based on the best available scientific information, which indicates the likely distribution of nesting birds is not as far inland as was delineated in 1996. We have no historical or current survey records documenting murrelet presence in the areas being removed in northern California, and the best available information indicates the inland range of the murrelet from the Pacific Ocean is delimited by the hemlock/tanoak habitat zone, rather than specific distance from the coast. Accordingly, we are revising the designation of critical habitat for the marbled murrelet from the 1996 critical habitat designation (61 FR 26254; May 24, 1996) to reflect the removal of approximately 189,700 ac (76,700 ha) of area from critical habitat designation in 8 units in southern Oregon and northern California. The critical habitat units affected by the revision are depicted in Table 1 and Table 2. The remaining critical habitat units that were designated in the May 24, 1996, final rule are not affected by this revision. Approximately 3,698,100 ac (1,497,000 ha) of critical habitat is now designated for the marbled murrelet.

Critical Habitat

Critical habitat is defined in section 3 of the Act as:

(1) The specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features

(a) Essential to the conservation of the species, and

(b) Which may require special management considerations or protection; and

(2) Specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.

Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot otherwise be relieved, may include regulated taking.

Critical habitat receives protection under section 7 of the Act through the requirement that Federal agencies ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Where a landowner seeks or requests Federal agency funding or authorization for an action that may affect a listed species or critical habitat, the consultation requirements of section 7(a)(2) of the Act would apply, but even in the event of a destruction or adverse modification finding, the obligation of the Federal action agency and landowner is not to restore or recover the species, but to implement reasonable and prudent alternatives to avoid destruction or adverse modification of critical habitat.

For inclusion in a critical habitat designation, habitat within the geographical area occupied by the species at the time of listing must contain the physical or biological features which are essential to the conservation of the species and which may require special management considerations or protection. Critical habitat designations identify, to the extent known using the best scientific and commercial data available, those physical or biological features that are essential to the conservation of the species (such as space, food, cover, and protected habitat), focusing on the principal biological or physical constituent elements (primary constituent elements, or PCEs) within an area that are essential to the conservation of the species (such as roost sites, nesting grounds, seasonal wetlands, water quality, tide, soil type). PCEs are the elements of physical and biological features that, when laid out in the appropriate quantity and spatial arrangement to provide for a species' life-history processes, are essential for the conservation of the species.

Under the Act, we can designate critical habitat in areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. We designate critical habitat in areas outside the geographical area occupied by a species only when a designation limited to its range would be inadequate to ensure the conservation of the species. When the best available scientific data do not demonstrate that the conservation needs of the species require such additional areas, we will not designate critical habitat in areas outside the geographical area occupied by the species. An area currently occupied by the species but that was not occupied at the time of listing may, however, be essential to the conservation of the species and may be included in the critical habitat designation.

Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific and commercial data available. Further, our Policy on Information Standards Under the Endangered Species Act (published in the Federal Register on July 1, 1994 (59 FR 34271)), the Information Quality Act (section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658)), and our associated Information Quality Guidelines provide criteria, establish procedures, and provide guidance to ensure that our decisions are based on the best scientific data available. They require our biologists, to the extent consistent with the Act and with the use of the best scientific and commercial data available, to use primary and original sources of information as the basis for recommendations to designate critical habitat.

When we are determining which areas should be designated as critical habitat, our primary source of information is generally the information developed during the listing process for the species. Additional information sources may include the recovery plan for the species, articles in peer-reviewed journals, conservation plans developed by States and counties, scientific status surveys and studies, biological assessments, or other unpublished materials and expert opinion or personal knowledge. Substantive comments received in response to proposed critical habitat designations are also considered. A five-year review summarizing the biological, ecological, and population information on the marbled murrelet was completed on June 12, 2009 (Service 2009). That report also evaluated current threats and how they may have changed since the species was listed. This information was considered in the completion of this revised designation, as was information from the 12-month Finding on a Petition to Remove the Marbled Murrelet from the List of Endangered and Threatened Wildlife (75 FR 3424; January 21, 2010). We also reviewed the scientific data and other information used to finalize the 1996 critical habitat designation, which included research published in peer-reviewed articles, agency reports, unpublished data, and various Geographic Information System (GIS) data layers (e.g., land cover type information, land ownership information, topographic information). We reviewed the conservation needs of the marbled murrelet described in the recovery plan (Service 1997), and considered new scientific information and data available from State, Federal, and tribal agencies, as well as academia and private organizations.

Habitat is dynamic, and species may move from one area to another over time. Furthermore, we recognize that designation of critical habitat at a particular point in time may not include all of the habitat areas that we may later determine are necessary for the recovery of the species. For these reasons, a critical habitat designation does not signal that habitat outside the designated area is unimportant or may not promote the recovery of the species. Areas that are important to the conservation of the species, both inside and outside the critical habitat designation, will continue to be subject to: (1) Conservation actions implemented under section 7(a)(1) of the Act, (2) regulatory protections afforded by the requirement in section 7(a)(2) of the Act for Federal agencies to ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species, and (3) the prohibitions of section 9 of the Act if actions occurring in these areas may affect the species. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans (HCPs), or other species conservation planning efforts if new information available at the time of these planning efforts calls for a different outcome.

Physical or Biological Features

In accordance with section 3(5)(A)(i) and 4(b)(1)(A) of the Act and regulations at 50 CFR 424.12, in determining which areas within the geographical area occupied at the time of listing to designate as critical habitat, we consider those physical or biological features essential to the conservation of the species and which may require special management considerations or protection. These include, but are not limited to:

(1) Space for individual and population growth and for normal behavior;

(4) Sites for breeding, reproduction, or rearing (or development) of offspring; and

(5) Habitats that are protected from disturbance or are representative of the historical, geographical, and ecological distributions of a species.

We derive the specific elements of physical or biological features required for the marbled murrelet from its biological needs as described in the “Background” section of the final rule designating critical habitat for the marbled murrelet. The PCEs identified in the May 24, 1996, final critical habitat designation (61 FR 26254) have not been revised and remain applicable to this final revision of critical habitat for the marbled murrelet.

Criteria Used To Identify Critical Habitat

The criteria used to identify critical habitat areas described in the May 24, 1996, Federal Register remain applicable to this final revision of critical habitat for the marbled murrelet. These include suitable nesting habitat, information on presence/absence and occupancy, proximity to marine foraging habitat, large contiguous blocks of nesting habitat, rangewide distribution, and adequacy of existing protection and management (61 FR 26265).

Final Revised Critical Habitat Designation

In our 1996 designation of marbled murrelet critical habitat, we considered several factors in determining whether particular units met the definition of critical habitat, including available survey data, the proximity to marine foraging habitat, and the presence of large contiguous blocks of suitable nesting habitat. The physical or biological features associated with marbled murrelet critical habitat focused on individual trees with potential nesting platforms, and forested areas within 0.8 kilometers (0.5 miles) of individual trees with potential nesting platforms that had a canopy height of at least one-half the site potential tree height (SPTH) (the average maximum height for trees given local growing conditions). We determined that these features were essential because they provided suitable nesting habitat for successful reproduction. On a landscape basis, we believed that forests with canopy height of at least one-half the SPTH were more likely to be occupied, and hence were more likely to contribute to the conservation of the marbled murrelet (61 FR 26264; May 24, 1996).

For the 1996 critical habitat designation, we used survey results (including those showing the lack of detections) as indicators of the presence or absence of marbled murrelets in specific areas. However, survey efforts were minimal in many areas, coverage of areas surveyed was discontinuous, and information was of limited use in designating critical habitat in some portions of the range (61 FR 26274; May 24, 1996). The original delineation of zone 2 was based on relatively few far-inland marbled murrelet records, and considered the lack of comprehensive inland surveys throughout its range. Because of this paucity of survey data, the actual inland range and distribution of this species were unknown (Hunter et al. 1998, p. 93). We stated in the 1996 final rule that we would continue to monitor and collect new information, and may revise the critical habitat designation in the future if new information supports a change (61 FR 26272; May 24, 1996).

We have reassessed the 1996 critical habitat designation in southern Oregon and northern California, after considering the results of extensive surveys in these areas. Although the best available information in 1996 indicated a high probability of occupancy after applying the critical habitat methodology, new information collected from site-specific surveys has since confirmed that marbled murrelets do not use these areas. Recovery task 4.1.4 in the 1997 Marbled Murrelet Recovery Plan recommends that a definition of suitable marbled murrelet habitat be developed for each conservation zone to determine and map appropriate areas for marbled murrelet recovery with greater accuracy (Service 1997, p. 149), and task 4.1.6 recommends intensive surveys to identify nesting areas and delineate the inland boundary of murrelet nesting habitat (Service 1997, p. 150). Intensive surveys that have been conducted since 1997 have given us a more comprehensive understanding of the species biological needs, and the specific areas that are essential for the recovery of the species. Those are the areas that should be the focus of collective recovery efforts, rather than areas that may experience infrequent or occasional use at low levels.

Accordingly, we have determined that the areas being removed are not essential to the conservation of the species and do not meet the definition of critical habitat. Zone 2 includes areas from 35 mi (56.3 km) to 50 mi (80.5 km) from marine environments, depending on geographic location (Thomas 1993 (FEMAT), p. IV-24). In zone 2 in northern California and southern Oregon, 189,671 ac (76,757 ha) are being removed where extensive surveys have demonstrated marbled murrelets are very unlikely to be found (Hunter et al. 1997, pp. 16-25; Schmidt et al. 2000, pp. 16-22). Both of these studies acknowledge that it is possible that marbled murrelets may occasionally use some portion of the study areas; however, if the species does occur, the number of individuals is probably very low. Accordingly, the habitat in these areas does not contain elements of the physical or biological features in an appropriate quantity and spatial arrangement that are essential for the conservation of the species.

We are, therefore, revising the 1996 final designation of critical habitat for the marbled murrelet to reflect the removal of three critical habitat units (CA-10-a, CA-11-c, and CA-11-d) and the revision of five critical habitat units (CA-01-d, CA-01-e, CA-11-b, OR-07-d, and OR-07-f) in northern California and southern Oregon. No other critical habitat units designated in the May 24, 1996, final rule are affected by this revision. Each of the designated areas are within the geographical area occupied by the species at the time of listing, contain the physical or biological features essential to the conservation of the species, and may require special management considerations or protection.

The critical habitat areas described below reflect the best available scientific information regarding areas that no longer meet the definition of critical habitat for the marbled murrelet in Zone 2, because they are not essential to the conservation of the species.

Table 1—Critical Habitat for the Marbled Murrelet Designated in 1996 and Removed in 2011 by StateStateAreas removed from designated critical habitatAcresHectaresCalifornia143,48758,068Oregon46,18418,690Washington00Total189,67176,758Table 2—Critical Habitat for the Marbled Murrelet Designated in 1996 and Removed in 2011 by Unit and OwnershipCritical habitat unitOwnershipAcres removedHectares

California: The units or portions thereof that are not essential to the conservation of the marbled murrelet (i.e., they no longer meet the definition of critical habitat) include CA-01-d (portion), CA-01-e (portion), CA-10-a (entire), CA-11-b (portion), CA-11-c (entire), and CA-11-d (entire).

Oregon: The units or portions thereof that are not essential to the conservation of the marbled murrelet (i.e., they no longer meet the definition of critical habitat), where they extend into Oregon include CA-01-e (entire), CA-10-a (entire), OR-07-d (portion), and OR-07-f (portion).

Washington: No revisions to the 1996 critical habitat designation.

Effects of Critical Habitat DesignationSection 7 Consultation

Section 7(a)(2) of the Act requires Federal agencies, including the Service, to ensure that any action they fund, authorize, or carry out is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of designated critical habitat of such species. In addition, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any agency action which is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of proposed critical habitat.

Decisions by the Fifth and Ninth Circuit Courts of Appeals have invalidated our regulatory definition of “destruction or adverse modification” (50 CFR 402.02) (see Gifford Pinchot Task Force v. U.S. Fish and Wildlife Service, 378 F.3d 1059 (9th Cir. 2004) and Sierra Club v. U.S. Fish and Wildlife Service et al. 245 F.3d 434, 442 (5th Cir. 2001)), and we do not rely on this regulatory definition when analyzing whether an action is likely to destroy or adversely modify critical habitat. Under the statutory provisions of the Act, we determine destruction or adverse modification on the basis of whether, with implementation of the proposed Federal action, the affected critical habitat would continue to serve its intended conservation role for the species.

If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency (action agency) must enter into consultation with us. Examples of actions that are subject to the section 7 consultation process are actions on State, tribal, local, or private lands that require a Federal permit (such as a permit from the U.S. Army Corps of Engineers under section 404 of the Clean Water Act (33 U.S.C. 1251 et seq.) or a permit from the Service under section 10 of the Act) or that involve some other Federal action (such as funding from the Federal Highway Administration, Federal Aviation Administration, or the Federal Emergency Management Agency). Federal actions not affecting listed species or critical habitat, and actions on State, tribal, local, or private lands that are not federally funded or authorized, do not require section 7 consultation.

As a result of section 7 consultation, we document compliance with the requirements of section 7(a)(2) through our issuance of:

(1) A concurrence letter for Federal actions that may affect, but are not likely to adversely affect, listed species or critical habitat; or

(2) A biological opinion for Federal actions that may affect, and are likely to adversely affect, listed species or critical habitat.

When we issue a biological opinion concluding that a project is likely to jeopardize the continued existence of a listed species or destroy or adversely modify critical habitat, we provide reasonable and prudent alternatives to the project, if any are identifiable, that would avoid the likelihood of jeopardy and/or destruction or adverse modification of critical habitat. We define “reasonable and prudent alternatives” (at 50 CFR 402.02) as alternative actions identified during consultation that:

(1) Can be implemented in a manner consistent with the intended purpose of the action,

(2) Can be implemented consistent with the scope of the Federal agency's legal authority and jurisdiction,

(3) Are economically and technologically feasible, and

(4) Would, in the Director's opinion, avoid the likelihood of jeopardizing the continued existence of the listed species and/or avoid the likelihood of destroying or adversely modifying critical habitat.

Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or relocation of the project. Costs associated with implementing a reasonable and prudent alternative are similarly variable.

Regulations at 50 CFR 402.16 require Federal agencies to reinitiate consultation on previously reviewed actions in instances where we have listed a new species or subsequently designated critical habitat that may be affected and the Federal agency has retained discretionary involvement or control over the action (or the agency's discretionary involvement or control is authorized by law). Consequently, Federal agencies may sometimes need to request reinitiation of consultation with us on actions for which formal consultation has been completed, if those actions with discretionary involvement or control may affect subsequently listed species or designated critical habitat.

Application of the Adverse Modification Standards

The analytical framework described in the Director's December 9, 2004, memorandum regarding application of the “destruction or adverse modification” standard is used to complete section 7(a)(2) analysis for Federal actions affecting marbled murrelet critical habitat. The key factor related to the adverse modification determination is whether, with implementation of the proposed Federal action, the affected critical habitat would continue to serve its intended conservation role for the species or retain those PCEs that relate to the ability of the area to support the species. Activities that may destroy or adversely modify critical habitat are those that alter the physical or biological features to an extent that appreciably reduces the conservation value of critical habitat for the marbled murrelet.

Generally, the conservation role of marbled murrelet critical habitat units is to support nesting, roosting, and other normal behaviors (61 FR 26256). To recover the species, it is also necessary to produce and maintain viable marbled murrelet populations that are well distributed throughout the respective Conservation Zones (Service 1997 p. 116). The range of the marbled murrelet has been subdivided by the Recovery Plan into six Marbled Murrelet Conservation Zones (Service 1997, pp. 125-130), based on the need for potentially different recovery actions in various portions of the marbled murrelet's range, and the need to maintain well-distributed populations. These zones include Puget Sound (Zone 1), Western Washington Coast Range (Zone 2), Oregon Coast Range (Zone 3), Siskiyou Coast Range (Zone 4), Mendocino (Zone 5), and the Santa Cruz Mountains (Zone 6). Marbled murrelets within the conservation zones are likely to interact across zone boundaries at some level.

Specific goals are described in the Recovery Plan, but generally include maintaining occupied sites and suitable nesting habitat for marbled murrelets. Because it will take 50 or more years to develop new nesting habitat, the short-term focus is on retaining and/or increasing terrestrial habitat (Service 1997 p. vi). For a wide-ranging species such as the marbled murrelet, where multiple critical habitat units are designated, each unit has a Conservation Zone role and range-wide role in contributing to the conservation of the species. The basis for an adverse modification opinion would be whether a proposed action appreciably reduces the ability of critical habitat to remain functional to serve its identified conservation role at the Conservation Zone and range-wide levels. In evaluating the effect of a proposed action, the Service will analyze the impacts to individual units in light of their overall contribution to the conservation of murrelets in the conservation zone described previously, and the overall range of the marbled murrelet in Washington, Oregon, and California. Thus, an adverse modification determination would be based upon a broader inquiry than an assessment of adverse effects at the local unit level.

Section 4(b)(8) of the Act requires us to briefly evaluate and describe, in any proposed or final regulation that designates critical habitat, activities involving a Federal action that may destroy or adversely modify such habitat, or that may be affected by such designation.

Activities that may affect critical habitat, when carried out, funded, or authorized by a Federal agency, should result in consultation for the marbled murrelet. These activities include, but are not limited to: (1) Forest management activities that greatly reduce stand canopy closure, appreciably alter the stand structure or reduce the availability of nesting sites; (2) land disturbance activities such as mining, sand and gravel extraction, construction of hydroelectric facilities and road building; and (3) harvest of certain types of commercial forest products (e.g. moss).

These activities may have the following effects on marbled murrelet critical habitat:

(1) Removal or degradation of individual trees with potential nesting platforms, or the nest platforms themselves, that results in a significant decrease in the value of the trees for future nesting use. Moss may be an important component of nesting platforms in some areas.

(2) Removal or degradation of trees adjacent to trees with potential nesting platforms that provide habitat elements essential to the suitability of the potential nest tree or platform, such as trees providing cover from weather or predators.

(3) Removal or degradation of forested areas with a canopy height of at least one-half the site-potential tree height and, regardless of contiguity, within 0.8 km (0.5 mi) of individual trees containing potential nest platforms. This includes removal or degradation of trees currently unsuitable for nesting that contribute to the structure/integrity of the potential nest area (i.e., trees that contribute to the canopy of the forested area). These trees provide the canopy, stand conditions, and protection from predators important for marbled murrelet nesting.

For a proposed action to result in destruction or adverse modification of critical habitat, it must affect the designated critical habitat to an extent that the affected unit(s) no longer serves its intended conservation role for the species or no longer retains its current ability for the PCEs to support the species. Proposed actions requiring a section 7 consultation must be evaluated individually, in light of the baseline condition of the critical habitat unit and Conservation Zone, unique history of the area, and effect of the impact on the critical habitat unit relative to its regional and range-wide role in the conservation of the species.

All of the units designated as critical habitat contain physical or biological features essential to the conservation of the marbled murrelet. All units are within the geographic range of the species, were occupied or were likely to have been occupied by the species at the time of listing, and are likely used by the marbled murrelet. Federal agencies already consult with us on activities in areas occupied by the marbled murrelet or if the species may be affected by the action, to ensure that their actions do not jeopardize the continued existence of the marbled murrelet.

Activities that have little to no effect to one critical habitat unit or Conservation Zone may result in serious effects in another, due to differences in existing conditions and the conservation function of critical habitat. Therefore, the Service cannot provide a detailed description of the threshold for future actions that would result in the destruction or adverse modification of critical habitat that would be applicable throughout the range of the designated critical habitat in this final rule.

Actions that impact forest stands that are not within 0.5 mile (0.8 km) of individual trees with potential nesting platforms would probably not adversely modify critical habitat, even if they occur within the boundaries of the area designated as critical habitat. Activities that do not affect the PCEs or the ability for the PCEs to support the species are unlikely to be affected by the designation. However, even though an action may not adversely affect or modify critical habitat, it may still affect marbled murrelets (e.g., through disturbance) and may, therefore, still be subject to consultation under section 7 of the Act.

Activities conducted according to the standards and guidelines for LSRs, as described in the Record of Decision for the Northwest Forest Plan, would be unlikely to result in the destruction or adverse modification of marbled murrelet critical habitat. Activities in these areas would be limited to manipulation of young forest stands that are not currently marbled murrelet nesting habitat. These forest management activities would be conducted in a manner that would not slow the development of these areas into future nesting habitat, and should speed the development of some characteristics of older forest.

If you have questions regarding whether specific activities may constitute destruction or adverse modification of critical habitat, contact a Field Supervisor listed under FOR FURTHER INFORMATION CONTACT.

ExemptionsApplication of Section 4(a)(3) of the Act

The Sikes Act Improvement Act of 1997 (Sikes Act) (16 U.S.C. 670a) required each military installation that includes land and water suitable for the conservation and management of natural resources to complete an integrated natural resource management plan (INRMP) by November 17, 2001. An INRMP integrates implementation of the military mission of the installation with stewardship of the natural resources found on the base. Each INRMP includes:

(1) An assessment of the ecological needs on the installation, including the need to provide for the conservation of listed species;

(2) A statement of goals and priorities;

(3) A detailed description of management actions to be implemented to provide for these ecological needs; and

(4) A monitoring and adaptive management plan.

Among other things, each INRMP must, to the extent appropriate and applicable, provide for fish and wildlife management; fish and wildlife habitat enhancement or modification; wetland protection, enhancement, and restoration where necessary to support fish and wildlife; and enforcement of applicable natural resource laws. The National Defense Authorization Act for Fiscal Year 2004 (Pub. L. 108-136) amended the Act to limit areas eligible for designation as critical habitat. Specifically, section 4(a)(3)(B)(i) of the Act (16 U.S.C. 1533(a)(3)(B)(i)) now provides: “The Secretary shall not designate as critical habitat any lands or other geographical areas owned or controlled by the Department of Defense, or designated for its use, that are subject to an integrated natural resources management plan prepared under section 101 of the Sikes Act (16 U.S.C. 670a), if the Secretary determines in writing that such plan provides a benefit to the species for which critical habitat is proposed for designation.”

Although we did receive comments from the U.S. Navy related to their INRMP at Naval Radio Station Jim Creek in Washington, we are unaware of any lands owned or managed by the DOD within the specific areas that were being considered for removal from the 1996 critical habitat designation, as identified in the proposed rule (73 FR 44678; July 31, 2008). Therefore, this final rule will not have any effect on DOD lands subject to section 4(a)(3)(B)(i) of the Act.

ExclusionsApplication of Section 4(b)(2) of the Act

Section 4(b)(2) of the Act states that the Secretary must designate and revise critical habitat on the basis of the best available scientific and commercial data after taking into consideration the economic impact, national security impact, and any other relevant impact of specifying any particular area as critical habitat. The Secretary may exclude an area from critical habitat if he determines that the benefits of such exclusion outweigh the benefits of specifying such area as part of the critical habitat, unless he determines, based on the best scientific and commercial data available, that the failure to designate such area as critical habitat will result in the extinction of the species. In making that determination, the statute on its face, as well as the legislative history, is clear that the Secretary has broad discretion regarding which factor(s) to use and how much weight to give to any factor. However, since this action involves removing critical habitat from the existing designation, rather than designating critical habitat in new areas, section 4(b)(2) of the Act is not applicable, given the narrow scope of the action described in the proposed rule.

The Office of Management and Budget (OMB) has determined that this rule is not significant and has not reviewed this rule under Executive Order (E.O.) 12866. OMB bases its determination upon the following four criteria:

(1) Whether the rule will have an annual effect of $100 million or more on the economy or adversely affect an economic sector, productivity, jobs, the environment, or other units of the government.

(2) Whether the rule will create inconsistencies with other Federal agencies' actions.

(3) Whether the rule will materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients.

(4) Whether the rule raises novel legal or policy issues.

Regulatory Flexibility Act (5 U.S.C. 601 et seq.)

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effects of the rule on small entities (small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. The Small Business Regulatory Enforcement Fairness Act amended the Regulatory Flexibility Act to require Federal agencies to provide a certification statement of the factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities.

This revision will result in an approximate 189,671-acre (76,757-ha) reduction in the critical habitat acreage designated in the May 24, 1996, final rule (61 FR 26256). No additional critical habitat is being designated by this revision, and the areas being removed from the 1996 critical habitat designation occur exclusively on Federal lands (with the exception of an approximate one-acre linear strip of State land within CHU OR-07-f). Accordingly, we are certifying that the revised designation will not have a significant economic impact on a substantial number of small entities, and a regulatory flexibility analysis is not required.

Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.)

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.), we make the following findings:

(1) This rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that would impose an enforceable duty upon State, local, or Tribal governments with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or tribal governments lack authority to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; Aid to Families with Dependent Children work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) A condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”

The designation of critical habitat does not impose a legally binding duty on non-Federal Government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions do not destroy or adversely modify critical habitat under section 7. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency. Furthermore, to the extent that non-Federal entities are indirectly impacted because they receive Federal assistance or participate in a voluntary Federal aid program, the Unfunded Mandates Reform Act would not apply; nor does critical habitat shift the costs of the large entitlement programs listed above on to State governments.

(2) This revision results in an approximate 189,671-ac (76,757-ha) reduction in the critical habitat acreage that was designated in the May 24, 1996, final rule (61 FR 26256). With the exception of a small linear strip of State-owned land in Unit OR-07-f, all of the acres being removed from the 1996 designation are on Federal lands. Accordingly, we do not believe that this rule will significantly or uniquely affect small governments because small governments will be affected only to the extent that any programs having Federal funds, permits, or other authorized activities must ensure that their actions will not adversely affect the critical habitat. This revision would remove a portion of the designated critical habitat, removing the need to consult on effects to critical habitat for those removed areas. Therefore, a Small Government Agency Plan is not required.

Takings—Executive Order 12630

In accordance with E.O. 12630 (Government Actions and Interference with Constitutionally Protected Private Property Rights), we have analyzed the potential takings implications of this revised designation of critical habitat for the marbled murrelet in a takings implications assessment. Critical habitat designation does not affect landowner actions that do not require Federal funding or permits, nor does it preclude development of habitat conservation programs or issuance of incidental take permits to permit actions that do require Federal funding or permits to go forward. The takings implications assessment concludes that this revised designation of critical habitat for the marbled murrelet does not pose additional takings implications for lands within or affected by the original 1996 designation.

Federalism—Executive Order 13132

In accordance with E.O. 13132 (Federalism), this rule does not have significant Federalism effects. A Federalism assessment is not required. In keeping with Department of the Interior and Department of Commerce policy, we requested information from, and coordinated development of, this final revised critical habitat designation with appropriate State resource agencies in California, Oregon, and Washington. During the public comment periods, we did not receive any comments from any State agency (see Summary of Comments and Recommendations section). We believe that the revised designation of critical habitat for the marbled murrelet will have little incremental impact on State and local governments and their activities, since the removal of approximately 189,671 ac (76,757 ha) of currently designated critical habitat would impose no additional restrictions beyond any that may already be in place.

Civil Justice Reform—Executive Order 12988

In accordance with E.O. 12988 (Civil Justice Reform), the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. We are revising the critical habitat designation in accordance with the provisions of the Act. This final rule uses standard property descriptions and identifies the elements of physical or biological features essential to the conservation of the species within the designated areas to assist the public in understanding the habitat needs of the marbled murrelet.

Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)

This rule does not contain any new collections of information that require approval by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This rule will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Government-to-Government Relationship With Tribes

In accordance with the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments (59 FR 22951), Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments) and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes.

This revision will result in an approximate 189,671-ac (76,757-ha) reduction in the critical habitat acreage that was designated in the May 24, 1996, final rule (61 FR 26256). None of the areas being removed are on tribal lands, and we did not receive any comments from tribal entities in response to the proposed rule.

National Environmental Policy Act (42 U.S.C. 4321 et seq.)

It is our position that, outside the jurisdiction of the United States Court of Appeals for the Tenth Circuit, we do not need to prepare environmental analyses as defined by the National Environmental Policy Act (42 U.S.C. 4321 et seq.) in connection with designating critical habitat under the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244). This assertion was upheld by the United States Court of Appeals for the Ninth Circuit (Douglas County v. Babbitt, 48 F.3d 1495 (9th Cir. 1995), cert. denied 516 U.S. 1042 (1996)).

Energy Supply, Distribution, or Use—Executive Order 13211

Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) requires agencies to prepare Statements of Energy Effects when undertaking certain actions. OMB has provided guidance for implementing this Executive Order that outlines nine outcomes that may constitute “a significant adverse effect” when compared to not taking the regulatory action under consideration. We do not expect this final rule to significantly affect energy supplies, distribution, or use, since it would involve removing approximately 189,700 ac (76,700 ha) of critical habitat from the existing critical habitat designation. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

References Cited

A complete list of all references cited in this rulemaking is available online at http://www.fws.gov/wafwo/or upon request from the Manager, Washington Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT).

Authors

The primary authors of this package are staff from the Pacific Region Ecological Services Offices.

2. Amend § 17.11(h), by revising the entry for “Murrelet, marbled” under “BIRDS” in the List of Endangered and Threatened Wildlife to read as follows:§ 17.11 Endangered and threatened wildlife.

(h) * * *

SpeciesCommon nameScientific nameHistoric rangeVertebrate population where endangered or threatenedStatusWhen listedCritical

habitat

Special rules* * * * * * *Birds* * * * * * *Murrelet, marbledBrachyramphus marmoratusU.S.A. (AK, CA, OR, WA), Canada (B.C.)U.S.A. (CA, OR, WA)T47917.95(b)NA* * * * * * * 3. In § 17.95(b), amend the entry for “Marbled Murrelet” as follows:a. Revise the heading to read as set forth below;b. Revise paragraph 3 to read as set forth below;c. Remove the index map for Oregon (“General configuration of final critical habitat in Oregon”) and add in its place the map titled “Critical Habitat for the Marbled Murrelet (Brachyramphus marmoratus) in Oregon”, as set forth below;d. Remove the index map for California (“General configuration of final critical habitat in California”) and add in its place the map titled “Critical Habitat for the Marbled Murrelet (Brachyramphus marmoratus) in California”, as set forth below;e. Remove the critical habitat description and map for Unit OR-07-d and add in its place new text and a new map for Unit OR-07-d as set forth below;f. Remove the critical habitat description and map for Unit OR-07-f and add in its place new text and a new map for Unit OR-07-f as set forth below;g. Remove the critical habitat description and map for Unit CA-01-d and add in its place new text and a new map for Unit CA-01-d as set forth below;h. Remove the critical habitat description and map for Unit CA-01-e and add in its place new text and a new map for Unit CA-01-e as set forth below;i. Remove the critical habitat description and map for Unit CA-10-a;j. Remove the critical habitat description and map for Unit CA-11-b and add in its place new text and a new map for Unit CA-11-b as set forth below;k. Remove the critical habitat description and map for Unit CA-11-c; andl. Remove the critical habitat description and map for Unit CA-11-d.17.95 Critical habitat—fish and wildlife.

(b) Birds.

Marbled Murrelet (Brachyramphus marmoratus)

3. A description of the critical habitat units follows. Where a critical habitat unit includes Federal lands within the boundaries of a Late Successional Reserve (LSR) established by the Northwest Forest Plan, the areas included within the LSR boundaries as they existed on May 24, 1996, remain designated as critical habitat. Critical habitat units do not include non-Federal lands covered by a legally operative incidental take permit for marbled murrelets issued under section 10(a) of the Act.

BILLING CODE 4310-55-PER05OC11.008ER05OC11.009

Unit OR-07-d: Curry and Josephine Counties, Oregon. From United States Fish and Wildlife Service 1:100,000 map; Gold Beach and Grants Pass, Oregon; 1995.

Critical habitat includes only Federal lands designated as Late Successional Reserves described within the following areas:

U.S. Customs and Border Protection (CBP) currently operates a border crossing known as Morses Line, Vermont, located within the port limits of the port of entry of Highgate Springs/Alburg, Vermont. CBP officers are stationed at the Morses Line border crossing to accept entries of merchandise, collect duties, and enforce various provisions of the customs and immigration laws. The Morses Line border crossing is an aging facility that requires extensive upgrades and significant financial resources to update the facility to today's modern standards of border crossings. Based on internal analyses, feedback from many individuals in the local community, and consultation with members of Congress, CBP is evaluating the potential closure of the Morses Line border crossing. CBP is seeking public comment on this potential closure.

DATES:

Comments must be received on or before December 5, 2011.

ADDRESSES:

You may submit comments identified by docket number, by one of the following methods:

Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the “Public Participation” heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov. Submitted comments may also be inspected on regular business days between the hours of 9 a.m. and 4:30 p.m. at the Office of International Trade, Customs and Border Protection, 799 9th Street, NW., 5th Floor, Washington, DC. Arrangements to inspect submitted comments should be made in advance by calling Mr. Joseph Clark at (202) 325-0118.

FOR FURTHER INFORMATION CONTACT:

Roger Kaplan, CBP Office of Field Operations, telephone (202) 325-4543. You may also visit CBP's Morses Line Web site at http://www.cbp.gov/MorsesLineInfo.

SUPPLEMENTARY INFORMATION:

Public Participation

Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of this advance notice of proposed rulemaking. CBP also invites comments that relate to the economic, environmental, or federalism effects that might result from this proposal.

Background

CBP ports of entry are locations where CBP officers and employees are assigned to accept entries of merchandise, clear passengers, collect duties, and enforce the various provisions of customs, immigration, agriculture, and related U.S. laws at the border. The term “port of entry” is used in the Code of Federal Regulations (CFR) in title 8 for immigration purposes and in title 19 for customs purposes. Concerning customs purposes, the list of designated CBP ports of entry is set forth in paragraph (b)(1) of section 101.3 of the CBP regulations (19 CFR 101.3(b)(1)). Paragraph (b)(1) also provides the corresponding limits of those ports, generally by reference to a Treasury Decision (T.D.). The port of entry of Highgate Springs/Alburg, Vermont is described in T.D. 77-165 and includes the Morses Line border crossing.

For immigration purposes, 8 CFR 100.4(a) lists ports of entry for aliens arriving by vessel and land transportation. These ports are listed according to location by districts and are designated as Class A, B, or C. Morses Line is included in this list, in District No. 22, as a Class A port of entry, meaning a port that is designated as a port of entry for all aliens arriving by any means of travel other than aircraft.

Built in 1934, the Morses Line facility is CBP's oldest land border crossing facility, and its capabilities reflect the design requirements of that time. Although the crossing has undergone some limited renovation since it was built, a new facility would be needed to meet modern operational, safety, and technological demands. For an analysis of both the costs of updating the crossing and the costs of closing the crossing, see the section of this document entitled: Executive Order 12866: Regulatory Planning and Review. As indicated in that section, CBP has determined that the net benefit of closing rather than updating the crossing would be about $5.5 million the first year and $640,000 each year after that. Among other things, the analysis takes into account that the Morses Line crossing is one of CBP's lesser trafficked crossings, processing about 40 vehicles a day, as well as the close proximity of other border crossings.

Potential Closure of the Border Crossing

After hearing initial concerns expressed by members of Congress and some of their constituents regarding expansion and modernization of the Morses Line border crossing and considering the net benefits regarding closure of the crossing, CBP decided to investigate whether closing the crossing would be preferable to undertaking a modernization project. The low volume of traffic utilizing the Morses Line crossing as well as the proximity of alternate crossings, suggest that the cost and expansion needed to modernize the crossing may not be justified. Therefore, CBP is conducting an evaluation to determine whether to close the Morses Line border crossing.

The closure of the Morses Line border crossing would mean that CBP officers would not be stationed there and that the road at the border would be secured. Persons wishing to cross the border would need to travel to the closest manned U.S. border crossing, which would most likely be Highgate Springs, which is about 17 miles west, in the port of entry of Highgate Springs/Alburg, Vermont or the West Berkshire crossing, which is about 10 miles east, in the port of entry of Richford, Vermont.

Obstacles To Modernizing the Border Crossing

The American Recovery and Reinvestment Act of 2009 (ARRA), Public Law 111-5 (Feb. 17, 2009), included funding for CBP to renovate various ports and crossings along the U.S.-Canadian border. CBP intended to use funds from ARRA to modernize the Morses Line border crossing. However, this funding has expired. Congress would now have to specifically appropriate funding and provide authorization for CBP to modernize the border crossing.

Also, for the Morses Line border crossing to remain open, CBP must build a new facility, which would require a larger land footprint. Thus, CBP will need to acquire private land adjacent to the existing facility. The current property owner remains strongly opposed to selling his land to CBP to expand the border crossing.

Public Consultations

On May 22, 2010, representatives from CBP held a town hall meeting in Morses Line, Vermont. The members of the public in attendance at this meeting conveyed their sentiment that the border crossing should be closed rather than expanded. Shortly after this meeting, CBP began the review process for closing the crossing. Since that time, members of the public have spoken out both in favor and opposition of the contemplated closure. The communities on both sides of the border have held several public meetings, including one on September 25, 2010, to protest the possible closure of the crossing.

Public Comments

In view of the community interest in this matter, CBP encourages the public to submit comments regarding the potential closure of the Morses Line border crossing.

Next Steps

If, after a full review and consideration of the public comments and other assessments, CBP determines that the Morses Line border crossing should be closed, CBP would publish a Notice of Proposed Rulemaking (NPRM) in the Federal Register, which would propose the closure. The NPRM would provide an additional opportunity for public comment. After the NPRM comment period closes, CBP would consider the public comments and determine whether to implement the NPRM as proposed by issuing a final rule. If CBP determines that the Morses Line crossing should remain open, CBP will publish a notice in the Federal Register withdrawing this ANPRM.

Congressional Notification

On July 9, 2010, the Commissioner of CBP notified Congress of the potential closure of the Morses Line border crossing, fulfilling the congressional notification requirements of 19 U.S.C. 2075(g)(2) and section 417 of the Homeland Security Act (6 U.S.C. 217).

Executive Order 12866: Regulatory Planning and Review

This Advance Notice of Proposed Rulemaking (ANPRM) is not a significant regulatory action under Executive Order 12866 and has not been reviewed by the Office of Management and Budget (OMB) under that order. Below is CBP's preliminary assessment of the benefits and costs of this potential regulatory action. While an assessment of benefits and costs is not generally included in an ANPRM, we include one here to provide the public with as much information as possible. We welcome comments on the analytical approach and the data used.

Baseline Conditions

Morses Line is one of CBP's lesser trafficked crossings, processing about 40 vehicles a day between 8 a.m. and midnight. The port of Highgate Springs assigns 6 full time staff to the crossing, costing about $668,000 per year, including benefits. In addition, CBP spends about $24,000 a year on operating expenses such as utilities and maintenance. The total annual cost of operating the crossing is about $692,000. CBP has determined that the Morses Line crossing requires significant renovation and expansion. We estimate that it would cost approximately $5 million to acquire the needed land and build facilities that meet all current safety and operational standards, so CBP would spend about $5.7 million the first year (construction plus operating costs) and $0.7 million each subsequent year if the crossing were to remain open.

Costs of Closing the Crossing

The costs of this potential closure fall into three categories—the cost to CBP to physically close the port, the cost to U.S. travelers to drive to the next nearest port, and the cost to the economy of lost tourism revenue resulting from potential decreased Canadian travel. We estimate that it would cost approximately $158,000 to physically close the port, which involves building road barricades, boarding up the building, and managing asbestos.

In addition to the cost to the government of closing the port, we must examine the impact of this regulation on U.S. travelers (per guidance provided in OMB Circular A-4, this analysis is focused on costs and benefits to U.S. entities). Approximately 14,600 vehicles cross from Canada into the United States each year at Morses Line. According to CBP's Boston Field Office, vehicles crossing into the United States in Vermont, New Hampshire, and Maine carry an average of 1.8 passengers, 31 percent of whom are U.S. citizens. Using these figures, we estimate that 26,280 passengers cross into the United States through Morses Line each year and 8,147 are U.S. citizens. If the crossing is closed, these travelers would need to travel to an alternate crossing which could cost them both time and money. CBP does not collect data on outbound travelers, but since Morses Line is used primarily for local travel, we assume that outbound traffic closely resembles inbound traffic.

There are two alternate crossings near Morses Line—Highgate Springs, which is about 17 miles west, and West Berkshire, which is about 10 miles east. The alternate crossing travelers may choose would depend on their point of origin and their destination. In general, the closer the point of origin or destination to Morses Line, the more the traveler would be affected by the closure.

Because CBP does not collect data on either a traveler's point of origin or destination, we used Google Maps' “Get Directions” feature to estimate the effect of the closure on travelers. Using this tool, we measured the distance and estimated time between each probable cross-border combination (Abbot's Corner to Morses Line, Moore's Crossing to Franklin, etc.). We assume that travelers will always take the fastest route. Because Morses Line is not on major routes, it would not be the fastest route for the vast majority of travelers originating in or traveling outside this area, so we only consider the immediate surrounding area in our analysis (current traffic volumes through Morses Line also support the assumption that travel is overwhelmingly local). We next measured the distance and estimated time for each combination assuming they could not travel through Morses Line.

By comparing the distance and travel time for the fastest route to those for the fastest route that does not use Morses Line, we calculate the effect of the crossing closure on both travel time and miles traveled. For example, traveling from Morgan's Corner to Morses Line currently takes 18 minutes. If the Morses Line crossing is closed, it would take an estimated 36 minutes, 18 minutes longer. Table 1 shows the effects of the closure on time traveled for the points considered. Table 2 shows the effect on miles traveled.

Because CBP does not collect data on the points of origin or destinations of travelers using Morses Line and because quality population data for these locations is not available, we assume that each route is used equally. Using this assumption probably overstates the costs of the closure because the area immediately surrounding Morses Line 1 (which would be impacted most by the closure) is sparsely populated when compared to areas farther from the crossing, such as Franklin or Highgate Springs. Using this assumption we estimate that those whose trip is affected by the closure of Morses Line would be delayed by an average of 8.19 minutes (0.137 hours) and 5.7 miles for a one-way trip.

1 The population of the zip code containing Morses Line and Franklin is approximately 1,500 people. http://vermont.hometownlocator.com/zip-codes/data,zipcode,05457.cfm.

In 2007, Industrial Economics, Inc. (IEc) conducted a study for CBP to develop “an approach for estimating the monetary value of changes in time use for application in [CBP's] analyses of the benefits and costs of major regulations.” 2 We follow the three-step approach detailed in IEc's 2007 analysis here to monetize the increase in travel time resulting from the closure of Morses Line: (1) Determine the local wage rate, (2) determine the purpose of the trip, and (3) determine the value of the travel delay as a result of this rule. We start by using the median hourly rate of $15.73 for Vermont, as the effects of the rule are local.3 We next determine the purpose of the trip. For the purposes of this analysis, we assume this travel will be personal travel and will be local travel. We identify the value of time multiplier recommended by the U.S. Department of Transportation (DOT) for personal, local travel, as 0.5.4 Finally, we account for the value of the travel delay. Since the added time spent traveling is considered more inconvenient than the baseline travel, we account for this by using a factor that weighs time inconvenienced more heavily than baseline travel time. This factor, 1.47, is multiplied by the average wage rate and the DOT value of time multiplier for personal, local travel for a travel time value of $11.56 per traveler ($15.73 × 0.5 × 1.47).5

2 Robinson, Lisa A. 2007. “Value of Time.” Submitted to U.S. Customs and Border Protection on February 15, 2007. The paper is contained in its entirely as Appendix D in the Regulatory Assessment for the April 2008 final rule for the Western Hemisphere Travel Initiative requirements in the land environment (73 FR 18384; April 3, 2008). See http://www.regulations.gov document numbers USCBP-2007-0061-0615 and USCBP-2007-0061-0616.

5 Wardman, M., “A Review of British Evidence on Time and Service Quality Valuations,” Transportation Research Part E, Vol. 37, 2001, pp. 107-128.

We next multiply the estimated number of U.S. citizens entering through Morses Line in a year (8,147) by the average delay (0.137 hours calculated above) to arrive at the number of additional hours U.S. citizens would be delayed as a result of this rule—1,116 hours. We multiply this by the value of travel time ($11.56) to arrive at the value of the additional driving time for U.S. citizens arriving in the United States once Morses Line is closed. Finally, we double this to reach a total time cost of a round trip for U.S. citizens of $25,802.

Besides the cost of additional travel time, we must consider the vehicular costs of a longer trip. We must first estimate the number of miles the closure of Morses Line would add to U.S. citizens' trips. The annual traffic arriving at Morses line is 14,600 vehicles. Since CBP does not track the number of vehicles entering by nationality, we estimate those owned by U.S. citizens. Since 31 percent of the passengers entering the United States by car in the Boston Field Office (which includes Morses Line) are U.S. citizens, we assume that 31 percent of the vehicles are owned by U.S. citizens. Therefore, we estimate that 4,526 U.S.-owned vehicles would be affected by this rule. We multiply this by the average increase in round trip distance of 11.4 miles for a total distance delay for U.S. owned vehicles of 51,596 miles. We next monetize the delay by applying the IRS's standard mileage rate for business travel of $0.50 to these vehicles, which includes fuel costs, wear-and-tear, and depreciation of the vehicle. Because this is an estimate for business travel, it may overstate slightly costs for leisure travelers using their vehicles on leisure activities. We estimate that a closure of Morses line would cost U.S. citizens $25,798 in additional vehicular costs (14,600 vehicles × 31 percent U.S. citizens × 11.4 miles × $0.50 per mile = $25,798).

The final cost we must consider is the cost to the economy of lost tourism revenue resulting from potential decreased Canadian travel. Because of the lack of local tourism data for this specific region, we are unable to monetize or quantify these costs. We therefore discuss this qualitatively.

Since both U.S. and foreign travelers would be inconvenienced by the closure of the Morses Line crossing, it is possible that fewer foreign travelers would choose to cross the border into the United States. To the extent that these visitors were spending money in the United States, local businesses would lose revenue. Since the average trip would only be lengthened by about 8 minutes, this effect would likely be very small. Also, it could be mitigated by U.S. citizens who would now choose to remain in the United States. We believe that the total impacts on the economy due to decreased travel to the United States are negligible.

In summary, the closure of the Morses Line crossing would cost CBP $158,000 in direct closure costs in the first year, and U.S. travelers $25,802 in time costs and $25,798 in vehicular costs annually. Total costs to close the port would thus be $210,000 in the first year and $52,000 each following year.

Net Effect of Closure

The costs to CBP of leaving the Morses Line crossing open would be $5.7 million the first year and $692,000 each following year. The costs of closing the crossing would be $210,000 the first year and $52,000 each following year. Thus, the net benefit of the crossing closure would be about $5.5 million the first year and $640,000 each year after the first year.

The U.S. Nuclear Regulatory Commission (NRC) is publishing for public comment a notice of receipt of a petition for rulemaking (PRM), dated May 5, 2011, and supplemented on August 3, 2011, which was filed with the NRC by Cheri Swensson (the petitioner), on behalf of the American Academy of Health Care Providers in the Addictive Disorders (the Academy). The petition was docketed by the NRC on September 9, 2011, and has been assigned Docket No. PRM-26-7. The petitioner requests that the NRC amend its regulations to include the Academy as one of the organizations authorized to certify a substance abuse expert.

DATES:

Submit comments by December 19, 2011. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.

ADDRESSES:

Please include Docket ID NRC-2011-0220 in the subject line of your comments. For additional instructions on submitting comments and instructions on accessing documents related to this action, see “Submitting Comments and Accessing Information” in the SUPPLEMENTARY INFORMATION section of this document. You may submit comments by any one of the following methods:

Comments submitted in writing or in electronic form will be posted on the NRC Web site and on the Federal rulemaking Web site, http://www.regulations.gov. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed.

The NRC requests that any party soliciting or aggregating comments received from other persons for submission to the NRC inform those persons that the NRC will not edit their comments to remove any identifying or contact information, and therefore, they should not include any information in their comments that they do not want publicly disclosed.

You can access publicly available documents related to this document using the following methods:

• NRC's Public Document Room (PDR): The public may examine and have copied, for a fee, publicly available documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

• NRC's Agencywide Documents Access and Management System (ADAMS): Publicly available documents created or received at the NRC are available online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS, which provides text and image files of the NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC's PDR reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to pdr.resource@nrc.gov.

• Federal Rulemaking Web site: Public comments and supporting materials related to this petition for rulemaking can be found at http://www.regulations.gov by searching on Docket ID NRC-2011-0220.

Background

Cheri Swensson, on behalf of the Academy, submitted a petition for rulemaking dated May 5, 2011, and supplemented on August 3, 2011. The petitioner requested that the NRC amend Title 10 of the Code of Federal Regulations (10 CFR), Section 26.187, “Substance abuse expert,” by including the Academy at Section 26.187(b)(5). The petitioner is the Executive Director for the Academy, which is an international credentialing body composed of psychologists, medical doctors, nurses, social workers, and counselors that provides care in areas such as alcohol and gambling addiction. In 2010, the Academy received its accreditation from the National Commission for Certifying Agencies (NCCA). The NRC has determined that the petition meets the threshold sufficiency requirements for a petition for rulemaking under 10 CFR 2.802, “Petition for rulemaking,” and the petition has been docketed as PRM-26-7. The NRC is requesting public comment on the petition for rulemaking.

Discussion of the Petition

The petitioner states that the Academy “is very interested in working alongside the NRC to ensure its substance abuse experts are qualified and adhere to the NRC's code of professionalism and ethical conduct through [the Academy's] Certified Addiction Specialist [CAS] certification.” The petitioner states that the Academy's CAS certification was accredited by the NCCA in 2010 and is a comprehensive credential offered by the Academy which includes competencies in alcohol addiction, drug addiction, sex addiction, eating disorders and gambling addiction. The petitioner claims that its certification requirements meet or exceed the NRC's requirements. The petitioner requests that the NRC amend § 26.187(b)(5) to include the Academy as one of the organizations authorized to certify a substance abuse expert.

The U.S. Small Business Administration (SBA or Agency) is proposing to amend its regulations to implement provisions of the Small Business Jobs Act of 2010, which pertain to small business subcontracting. SBA is proposing to amend its regulations to provide for a “covered contract” (a contract for which a small business subcontracting plan is required, currently valued above $1.5 million for construction and $650,000 for all other contracts), a prime contractor must notify the contracting officer in writing whenever the prime contractor does not utilize a subcontractor used in preparing its bid or proposal during contract performance. SBA is also proposing to amend its regulations to require a prime contractor to notify a contracting officer in writing whenever the prime contractor reduces payments to a subcontractor or when payments to a subcontractor are 90 days or more past due. In addition, SBA is proposing to clarify that the contracting officer is responsible for monitoring and evaluating small business subcontracting plan performance. SBA is also proposing to clarify which subcontracts must be included in subcontracting data reporting, which subcontracts should be excluded, and the way subcontracting data is reported.

SBA is also proposing to make other changes to update its subcontracting regulations, including changing subcontracting plan thresholds and referencing the electronic subcontracting reporting system (eSRS). Some of the SBA's proposed changes would require the contracting officer to review subcontracting plan reports within 60 days of the report ending date.

SBA will post all comments on http://www.regulations.gov. If you wish to submit confidential business information (CBI) as defined in the User Notice at http://www.Regulations.gov, please submit the information to Dean Koppel, U.S. Small Business Administration, Office of Government Contracting, 409 Third Street, SW., 8th Floor, Washington, DC 20416, or send an e-mail to Dean.Koppel@sba.gov. Highlight the information that you consider to be CBI and explain why you believe SBA should hold this information as confidential. SBA will review the information and make the final determination on whether it will publish the information or not.

Section 1321 of the Jobs Act requires the SBA Administrator, in consultation with the Administrator of the Office of Federal Procurement Policy, to publish regulations establishing policies for subcontracting compliance, including assignment of compliance responsibilities between contracting offices, small business offices, and program offices. A 2010 Senate Report to a bill (S. 2989) that contained many of the same or similar provisions to the subcontracting provisions in the Jobs Act cites a 2005 Government Accountability Office (GAO) report concerning the Department of Energy, where GAO found that large business prime contractors had overstated their small business subcontracting achievements by excluding certain subcontracts from the base, such as electricity and utilities, thereby making it appear that the prime contractor awarded a much higher percentage of its subcontracts to small business concerns than the prime contractors actually awarded. S. Rep. No. 111-343, “Small Business Contracting Revitalization Act of 2010,” September 29, 2010; “Department of Energy, Improved Oversight Could Better Ensure Opportunities for Small Business Subcontracting,” GAO Report No. 05-459 (May 2005).

While SBA recognizes the valuable insight provided by GAO in the above-referenced report, it does not concur with all of GAO's findings. For example, SBA does not believe that electricity and utilities (e.g., water, sewer, and refuse collection purchased from a municipality) belong in the subcontracting base. Including electricity and other utilities in the base creates the illusion that there are more subcontracting opportunities for small business than are actually available. SBA is proposing to define subcontract so that prime contractors and contracting officers will no longer be confused about which subcontracts must be included when reporting on small business subcontracting performance. For example, when preparing its individual subcontracting plan, a prime contractor must decide whether or not to include indirect costs in the subcontracting base, for both goaling and reporting purposes. Indirect costs must be included in a commercial plan to ensure comparability between goals and achievements because companies with commercial plans file only a summary report, not an individual report. All contractors must include indirect costs in their summary subcontracting reports.

In addition, GAO recommended that prime contractors report subcontracting to small businesses as a percentage of total contract dollars. Under current reporting requirements, prime contractors report subcontracting achievement in whole dollars and as a percentage of eligible subcontracts. SBA believes that subcontracting should be reported as a percentage of total subcontracting dollars rather than as a percentage of total contract dollars. The Small Business Act establishes government goals for socioeconomic groups based on a percentage of total subcontracted dollars, not total contract dollars. 15 U.S.C. 644(g)(1). However, SBA is proposing to explicitly authorize contracting officers to establish additional goals in terms of total contract dollars. Contracting officers are already doing this, and when a prime contractor enters its subcontracting achievements (i.e., dollars) into eSRS, the system automatically calculates the percentage by both methods—i.e., as a percentage of total subcontracting and as a percentage of total contract dollars. Thus, the contracting officer has the ability to compare achievements against the total contract dollars if desired.

GAO also found that there was confusion within the procuring agency about who was responsible for monitoring small business subcontracting plan performance. SBA is proposing to amend its regulations to make it clear that contracting officers (or administrative contracting officers if applicable) are responsible for monitoring and evaluating the prime contractor's small business subcontracting plan compliance and reporting. SBA is proposing to require the cognizant contracting officer to review every prime contractor's Individual Subcontract Report (ISR) or Subcontracting Report for Individual Contracts, SF 294, if authorized, or when applicable, the Summary Subcontract Report (SSR) for a commercial plan, within 60 days of the report ending date (e.g., by November 30th for a report submitted for the fiscal year ended September 30th) and accept or reject the report in accordance with the Federal Acquisition Regulation (FAR) provisions set forth in subpart 19.7 and the eSRS instructions (http://www.esrs.gov).

All contractors whose reports are rejected, including those with individual contract plans and commercial plans as defined in FAR 19.701, will be required to make the necessary corrections and resubmit their reports within 30 days of receiving the notice of rejection.

SBA is also proposing to address subcontracting plans in connection with Multi-Agency, Federal Supply Schedule, Multiple Award Schedule and Government-wide Acquisition IDIQ contracts. Funding agencies have expressed interest in receiving credit towards their subcontracting goals for orders placed against another agency's task or delivery order contract. SBA is proposing that the contracting officer for the IDIQ contract will establish subcontracting plans for contractors without commercial plans. The contractor will report small business subcontracting achievement on an order-by-order basis to the contracting officer for the contracting agency. Contractors are currently reporting information on all orders collectively on a semi-annual or annual basis. Reporting on an order-by-order basis will allow the funding agency to receive credit towards its small business subcontracting goals. SBA is requesting comments on whether the reporting requirement should apply to all orders, or only apply to orders above a certain threshold. SBA is also proposing to allow the funding agency contracting officer the discretion to establish goals in connection with individual orders.

SBA is proposing that contracting officers require prime contractors to update subcontracting plans whenever an option is exercised, as currently required by FAR 19.705-2(e). SBA is also proposing to require subcontracting plans whenever a modification causes a contract to exceed the subcontracting plan threshold. As currently written the FAR only requires a subcontracting plan if the value of the modification exceeds the subcontracting threshold. SBA is also proposing to allow the contracting officer to request a subcontracting plan when a firm's status changes from small to other than small as a result of a size recertification.

Section 1322 of the Jobs Act established a requirement that a prime contractor on a covered contract must notify the contracting officer in writing if the prime contractor fails to utilize a small business concern used in preparing and submitting the prime contractor's bid or proposal. Defining when a prime used a subcontractor in preparing a bid or proposal is very difficult. For example, providing a quote, or discussing availability, does not rise to the level of collaboration that would require notice to the Government. Consequently, we are proposing that the notice required by the statute will be triggered when: (1) The offeror specifically references a small business concern in a bid or proposal, (2) the offeror has entered into a written agreement with the small business concern for purposes of performing the specific contract as a subcontractor, or (3) the small business concern drafted portions of the proposal or submitted pricing or technical information that appears in the bid or proposal, with the intent or understanding that the small business concern will perform that related work if the offeror is awarded a contract.

Section 1334 of the Jobs Act established a requirement that a prime contractor notify the contracting officer in writing whenever a payment to a subcontractor is reduced or is 90 days or more past due for goods and services provided for the contract and for which the Federal agency has paid the contractor. The prime contractor shall include the reason for the reduction in payment to or failure to pay a subcontractor in the written notice. The contracting officer must consider the prime contractor's unjustified untimely or reduced price payments to subcontractors when evaluating the prime contractor's performance.

In addition, we are proposing that the contracting officer should consider whether to require a prime contractor to enter into a funds control agreement with a neutral third party if the prime contractor fails to pay subcontractors in a timely manner or fails to pay the agreed upon contractual price without justification. S. Rep. No. 111-343, p. 15. SBA is specifically requesting comments on how these arrangements work in the commercial sector, and specific language which can be used to guide contracting officers on the use of such an arrangement.

As required by the statute, SBA is also proposing that the contracting officer must record the identity of a prime contractor with a history of unjustified, untimely payments to subcontractors in the Federal Awardee Performance and Integrity System or any successor system. SBA is proposing to define a history of unjustified untimely or reduced payments as three incidents within a 12 month period. SBA invites comments on the proposed definition or alternatives with supporting rationales, or comments on whether such judgments should be left to the discretion of the contracting officer.

SBA is proposing to update its regulations to increase the subcontracting plan thresholds which were increased pursuant to the government-wide procurement program inflationary adjustments required by Section 807 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005, Public Law 108-375, see also 75 FR 53129 (Aug. 30, 2010). SBA proposes to reference eSRS instead of SF-294 and SF-295 (where appropriate). SBA proposes to clarify that compliance reviews include reviews to determine whether the prime has assigned the subcontract the correct NAICS code and corresponding size standard, and whether the subcontractor qualifies under the size or socioeconomic status claimed. In addition, SBA is proposing to update its regulations to specify that a compliance review includes analysis of whether the prime contractor is monitoring its subcontractors with respect to their subcontracting plans, achievement of their subcontracting goals and reviewing their ISRs or other reports.

The Office of Management and Budget (OMB) has determined that this proposed rule is a significant regulatory action for purposes of Executive Order 12866. Accordingly, the next section contains SBA's Regulatory Impact Analysis. This is not a major rule, however, under the Congressional Review Act, 5 U.S.C. 801, et. seq.

Regulatory Impact Analysis

1. Is there a need for the regulatory action? The proposed regulations implement Sections 1321, 1322 and 1334 of the Small Business Jobs Act of 2010, Public Law 111-240, 124 Stat. 2504, September 27, 2010 (Jobs Act); 15 U.S.C. 637(d)(6)(G), (d)(12). Section 1321 of the Jobs Act requires the Administrator to establish a policy on subcontracting compliance within one year of enactment.

2. What are the potential benefits and costs of this regulatory action?

The proposed regulations will benefit small business subcontractors by encouraging large business prime contractors to pay small business subcontractors in a timely manner and the agreed upon contractual price. The proposed regulations will benefit small business subcontractors by encouraging large business contractors to utilize small business concerns in contract performance where the prime contractor used the small business concern to prepare the bid or proposal. The proposed regulations will benefit small business subcontractors by clarifying the responsibilities of the contracting officer in monitoring small business subcontracting plan compliance. The proposed regulations will benefit small business subcontractors by specifically authorizing procuring agencies to consider proposed small business subcontracting when evaluating offers.

The proposed regulations will benefit small business subcontractors by requiring large business concerns to report subcontracting results on an order-by-order basis, thereby enabling the funding agency to more closely monitor small business subcontracting in connection with the order and enabling the funding agency to receive credit towards its small business subcontracting goals. The proposed rule benefits funding agencies by allowing them to receive credit towards their subcontracting goals. The proposed rule benefits small business subcontractors by providing transparency with respect to small subcontracting on an order-by-order basis, thereby allowing the funding agency to monitor performance, and in its discretion, establish subcontracting goals for particular orders.

eSRS will have to be altered to allow large business prime contractors to report subcontracting results on an order-by-order basis. Other systems may have to be altered to allow funding agencies to receive credit towards their small business subcontracting goals. Large business prime contractors will have to submit subcontracting reports more frequently.

Large businesses will have to report to the contracting officer in writing when they fail to utilize a small business concern in contract performance when the prime contractor utilized the small business concern in preparing the bid or proposal. Large businesses will have to report to the contracting officer in writing when they fail to pay a subcontractor within 90 days or when they pay a subcontractor a reduced price. The contracting officer will have to consider these written explanations when evaluating contract performance. The Federal Awardee Performance and Integrity System will have to be modified to allow contracting officers to identify large business prime contractors with a history of unjustified untimely payments.

3. What are the alternatives to this final rule?

Many of the proposed regulations are required to implement statutory provisions, and the Jobs Act requires promulgation of a policy on subcontracting compliance with within one year of enactment. The alternative to the proposed regulation concerning orders would be to maintain the current environment, where subcontracting results are not reported on an order-by-order basis, and agencies funding orders do not receive credit towards their small business subcontracting goals.

Executive Order 13563

As part of its ongoing efforts to engage stakeholders in the development of its regulations, SBA has solicited comments and suggestions from procuring agencies on how to best implement the Jobs Act. SBA held public forums around the country to discuss implementation of the Jobs Act. SBA has incorporated, where feasible, public input into the proposed rule. The proposed regulations concerning evaluation factors provide contracting officers with the discretion to utilize various methods to improve small business subcontracting, without requiring their use in all cases. The proposed rule concerning orders will provide contracting agencies with transparency by providing data concerning small business subcontracting for particular orders. Overall, these regulations would minimize the burden resulting from these proposed amendments. SBA is proposing to amend its regulations to remove outmoded thresholds that have increased and remove references to paper based forms that have been replaced by electronic reporting through eSRS.

As part of its implementation of this executive order and consistent with its commitment to public participation in the rulemaking process, SBA held public meetings in 13 locations around the country to discuss implementation of the Jobs Act, and received public input from thousands of small business owners, contracting officials and large business representatives. Although most of these amendments are new, SBA expects that public participation will help to form the Agency's retrospective analysis of related contracting regulations that are not being amended at this time.

Executive Order 12988

For purposes of Executive Order 12988, SBA has drafted this proposed rule, to the extent practicable, in accordance with the standards set forth in section 3(a) and 3(b)(2) of that Order, to minimize litigation, eliminate ambiguity, and reduce burden. This rule has no preemptive or retroactive effect.

Executive Order 13132

This rule does not have federalism implications as defined in Executive Order 13132. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various layers of government, as specified in the order. As such it does not warrant the preparation of a Federalism Assessment.

Paperwork Reduction Act, 44 U.S.C. Ch. 35

For the purpose of the Paperwork Reduction Act, SBA has determined that this rule, if adopted in final form, would impose new government-wide reporting requirements on large prime contractors. The Jobs Act requires such contractors to notify contracting officers, at the applicable procuring agency, in writing whenever a prime contractor fails to utilize a small business subcontractor used in preparing and submitting a bid or proposal; when the prime contractor pays a subcontractor a reduced price without justification; or when payments to a subcontractor are 90 days or more past due. These requirements will also be incorporated in the Federal Acquisition Regulations.

Regulatory Flexibility Act, 5 U.S.C. 601-612

SBA has determined that this proposed rule, if adopted in final form, may have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612. Therefore, SBA has prepared an Initial Regulatory Flexibility Act (IRFA) analysis addressing the proposed regulation.

IRFA

When preparing a Regulatory Flexibility Analysis, an agency shall address all of the following: a description of why the action by the agency is being considered; the objectives and legal basis of the rule; the estimated number of small entities to which the rule may apply; a description of the projected reporting, recordkeeping and other compliance requirements; identification of all Federal rules which may duplicate, overlap or conflict with the proposed rule; and a description of significant alternatives which minimize any significant economic impact on small entities. This IRFA considers these points and the impact the proposed regulation concerning subcontracting may have on small entities.

(a) Need for, Objectives, and Legal Basis of the Rule

The majority of the proposed regulatory amendments are required to implement Sections 1321, 1322 and 1334 of the Small Business Jobs Act of 2010, Public Law 111-240, 124 Stat. 2504, September 27, 2010 (Jobs Act); 15 U.S.C. 637(d)(6)(G), (d)(12). The proposed regulations that are not required by the Jobs Act are intended to help small business subcontractors by explicitly authorizing procuring agencies to consider proposed small business participation when evaluating offers from other than small business concerns, and to require other than small prime contractors to report data on small business subcontracting in connection with certain orders.

(b) Estimate of the Number of Small Entities to Which the Rule May Apply

The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of entities that may be affected by the proposed rules, if adopted. The RFA defines “small entity” to include “small businesses,” “small organizations,” and “small governmental jurisdictions.” SBA's programs generally do not apply to “small organizations” or “small governmental jurisdictions” because they are non-profit or governmental entities and do not generally qualify as “business concerns” within the meaning of SBA's regulations. SBA's programs generally apply only to for-profit business concerns. However, to the extent this rule will impact small organizations or small governmental jurisdictions that receive prime contracts from the Federal government with values that exceed the threshold, the numbers would be minimal, and the major provisions would only apply if the entity fails to pay or utilize small business subcontractors.

The proposed rule will not directly negatively affect any small business concern, because it applies to other than small concerns and contracting officers. The proposed rule will indirectly benefit small business concerns, by requiring other than small prime contractors to report to the contracting officer when the prime contractor has failed to utilize a small business subcontractor used in preparing the bid or proposal. The proposed rule will also indirectly benefit small business concerns, by requiring large business prime contractors to report to the contracting officer when the prime contractor has failed to pay a small business subcontractor in a timely manner or pays a subcontractor a reduced rate without justification.

There are in approximately 348,000 concerns listed as small business concerns in the Dynamic Small Business Search (DSBS) database. We do not know how many of these concerns participate in small business subcontracting. Firms do not need to register in the DSBS database to participate in subcontracting. The DSBS database is primarily used for prime contracting purposes. Thus, the number of firms participating in subcontracting may be greater than or lower than the number of firms registered in the DSBS database.

To the extent the proposed rule imposes new information collection, recordkeeping or compliance requirements, they are imposed on other than small business concerns, not on small business concerns.

(d) Federal Rules Which May Duplicate, Overlap or Conflict With the Proposed Rule

SBA is not aware of any rules which duplicate, overlap or conflict with the proposed rule. The proposed rule primarily implements statutory provisions.

(e) Significant Alternatives to the Rule Which Could Minimize Impact on Small Entities

Section 1321 of the Jobs Act requires SBA to promulgate regulations implementing it. Section 1321 of the Jobs Act and its proposed implementing regulations primarily apply to contracting officers. Sections 1322 and 1334 of the Jobs Act amend portions of the Small Business Act, which SBA is responsible for administering and implementing through its regulations. The proposed rules implementing Sections 1322 and 1334 of the Jobs Act primarily apply to other than small concerns. As discussed above, the proposed rule indirectly benefits small business concerns, without requiring small business concerns to report, keep records or take other compliance actions.

List of Subjects13 CFR Part 121

Government procurement, Government property, Grant programs—business, Individuals with disabilities, Loan programs—business, Small businesses.

13 CFR Part 125

Government contracting programs; Small business subcontracting program.

For the reasons stated in the preamble, SBA proposes to amend parts 121 and 125 of title 13 of the Code of Federal Regulations as follows:

PART 121—SMALL BUSINESS SIZE REGULATIONS

1. The authority citation for 13 CFR part 121 continues to read as follows:

(a) General. The purpose of the subcontracting assistance program is to provide the maximum practicable subcontracting opportunities for small business concerns, including small business concerns owned and controlled by veterans, small business concerns owned and controlled by service-disabled veterans, certified HUBZone small business concerns, certified small business concerns owned and controlled by socially and economically disadvantaged individuals, and small business concerns owned and controlled by women. The subcontracting assistance program implements section 8(d) of the Small Business Act, which includes the requirement that, unless otherwise exempt, other-than-small business concerns awarded contracts that offer subcontracting possibilities by the Federal Government in excess of $650,000, or in excess of $1,500,000 for construction of a public facility, must submit a subcontracting plan to the appropriate contracting agency. The Federal Acquisition Regulation sets forth the requirements for subcontracting plans in 48 CFR 19.7, and the clause at 48 CFR 52.219-9.

(1) Subcontract under this section means any agreement (other than one involving an employer-employee relationship) entered into by a Government prime contractor or subcontractor calling for supplies and/or services required for performance of the contract or subcontract (including modifications). Purchases from a corporation, company, or subdivision that is an affiliate of the prime contractor or subcontractor are not included. Subcontract award data reported by prime contractors and subcontractors shall be limited to awards made to their immediate next-tier subcontractors. Credit cannot be taken for awards made beyond the immediate next-tier, unless the contractor or subcontractor has been designated to receive a small business or small disadvantaged business credit from an ANC or Indian Tribe. Only subcontracts involving performance in the United States or its outlying areas should be included, with the exception of subcontracts under a contract awarded by the State Department or any other agency that has statutory or regulatory authority to require subcontracting plans for subcontracts performed outside the United States and its outlying areas and subcontracts for foreign military sales unless waived in accordance with agency regulations. The following should not be included in the subcontracting base: Internally generated costs such as salaries and wages, employee insurance; other employee benefits; payments for petty cash; depreciation; interest; income taxes; property taxes; lease payments; bank fees; fines, claims, and dues; Original Equipment Manufacturer relationships during warranty periods (negotiated up front with product); electricity; utilities such as water, sewer, and other services purchased from a municipality; and philanthropic contributions. Utility companies may be eligible for additional exclusions unique to their industry, which may be approved by the contracting officer on a case-by-case basis.

(2) Subcontracting goals required under paragraph (c) must be established in terms of the total dollars subcontracted and as a percentage of total subcontract dollars. However, a contracting officer may establish additional goals as a percentage of total contract dollars.

(3) A prime contractor has a history of unjustified untimely or reduced payments to subcontractors if the prime contractor has reported itself to a contracting officer in accordance with paragraph (c)(5) on three occasions within a 12 month period.

(b) Responsibilities of prime contractors. (1) Prime contractors (including small business prime contractors) selected to receive a Federal contract that exceeds the simplified acquisition threshold, that will not be performed entirely outside of any state, territory, or possession of the United States, the District of Columbia, or the Commonwealth of Puerto Rico, and that is not for services which are personal in nature, are responsible for ensuring that small business concerns have the maximum practicable opportunity to participate in the performance of the contract, including subcontracts for subsystems, assemblies, components, and related services for major systems, consistent with the efficient performance of the contract.

(c) Additional responsibilities of large prime contractors. (1) In addition to the responsibilities provided in paragraph (b) of this section, a prime contractor selected for award of a contract or contract modification that exceeds $650,000, or $1,500,000 in the case of construction of a public facility, is responsible for:

(iii) A prime contractor may not prohibit a subcontractor from discussing any material matter pertaining to payment or utilization as set forth in paragraph (c) with the contracting officer;

(iv) When developing an individual subcontracting plan (also called individual contract plan), the contractor must decide whether to include indirect costs in its subcontracting goals. If indirect costs are included in the goals, these costs must be included in the Individual Subcontract Report (ISR) in http://www.esrs.gov (eSRS) or Subcontract Reports for Individual Contracts (the paper SF-294 (if authorized). If indirect costs are excluded from the goals, these costs must be excluded from the ISRs (or SF-294 if authorized); however, these costs must be included on a prorated basis in the Summary Subcontracting Report (SSR) in the eSRS system. A contractor authorized to use a commercial subcontracting plan must include all indirect costs in its SSR;

(v) Assigning each subcontract the NAICS code and corresponding size standard that best describes the principal purpose of the subcontract (see 121.410);

(vi) Submitting timely and accurate ISRs and SSRs in eSRS, or if information for a particular procurement cannot be entered into eSRS, submit a timely SF-294, Subcontracting Report for Individual Contract. When a report is rejected by the contracting officer, the contractor must make the necessary corrections and resubmit the report within 30 days of receiving the notice of rejection;

(viii) Providing pre-award written notification to unsuccessful small business offerors on all subcontracts over $150,000 for which a small business concern received a preference. The written notification must include the name and location of the apparent successful offeror and if the successful offeror is a small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, or women-owned small business; and

(ix) As a best practice, providing the pre-award written notification cited in paragraph (c)(1)(viii) of this section to unsuccessful and small business offerors on subcontracts at or below $150,000 whenever it is practical to do so.

(3) An offeror must represent to the contracting officer that it will make a good faith effort to acquire articles, equipment, supplies, services, or materials, or obtain the performance of construction work from the small business concerns that it used in preparing the bid or proposal, in the same amount and quality used in preparing and submitting the bid or proposal. An offeror used a small business concern in preparing the bid or proposal if:

(i) The offeror references the small business concern as a subcontractor in the bid or proposal;

(ii) The offeror has a subcontract or agreement in principle to subcontract with the small business concern to perform a portion of the specific contract; or

(iii) The small business concern drafted any portion of the bid or proposal or the offeror used the small business concern's pricing or cost information or technical expertise in preparing the bid or proposal, where there is an intent or understanding that the small business concern will be awarded a subcontract for the related work if the offeror is awarded the contract.

(4) If an offeror fails to acquire articles, equipment, supplies, services or materials or obtain the performance of construction work as described in paragraph (c)(3) of this section, the offeror must provide the contracting officer with a written explanation.

(5) A prime contractor shall notify the contracting officer in writing if the prime contractor pays a reduced price to a subcontractor for goods and services upon completion of the responsibilities of the subcontractor or the payment to a subcontractor is more than 90 days past due for goods and services provided for the contract and for which the Federal agency has paid the prime contractor. The prime contractor shall include the reason for the reduction in payment to or failure to pay a subcontractor in any written notice.

(d) Contracting officer responsibilities. The contracting officer (or administrative contracting officer if specifically delegated in writing to accomplish this task) is responsible for evaluating the prime contractor's compliance with its subcontracting plan, including:

(1) Ensuring that all contractors submit their subcontracting reports into the eSRS or, if applicable, the SF-294, Subcontracting Report for Individual Contracts, within 30 days after the report ending date (e.g., by October 30th for the fiscal year ended September 30th);

(2) Reviewing all reports in eSRS within 60 days of the report ending date (e.g., by November 30th for a report submitted for the fiscal year ended September 30th);

(3) Evaluating whether the prime contractor made a good faith effort to comply with its small business subcontracting plan. Evidence that a large business prime contractor has made a good faith effort to comply with its subcontracting plan or other subcontracting responsibilities includes supporting documentation that:

(i) The contractor performed one or more of the actions described in paragraph (b) of this section, as appropriate for the procurement;

(ii) Although the contractor may have failed to achieve its goal in one socioeconomic category, it overachieved its goal by an equal or greater amount in one or more of the other categories; or

(iii) The contractor fulfilled all of the requirements of its subcontracting plan.

(4) Evaluating the prime contractor's written explanation concerning the prime contractor's failure to use a small business concern in performance when the prime contractor used the small business concern to prepare the bid or proposal.

(5) Evaluating the prime contractor's written explanation concerning its payment of a reduced price to a subcontractor for goods and services upon completion of the responsibilities of the subcontractor or its payment to a subcontractor more than 90 days late for goods and services provided for the contract and for which the Federal agency has paid the prime contractor.

(6) Evaluating whether a prime contractor that has failed to pay subcontractors in a timely manner or failed to pay subcontractors an agreed upon contractual price without justification should be required to enter into a funds control agreement with a neutral third party for the purpose of paying subcontractors the contractual amount in a timely manner.

(7) Evaluating whether the prime contractor has a history of unjustified untimely or reduced payments to subcontractors, and if so, recording the identity of the prime contractor in the Federal Awardee Performance and Integrity Information System (FAPIIS), or any successor database.

(8) A contracting officer must require the prime contractor (other than a prime contractor with a commercial plan) to update its subcontracting plan when an option is exercised.

(9) A contracting officer must require the prime contractor (other than a contractor with a commercial plan) to submit a subcontracting plan if the value of a modification causes the value of the contract to exceed the subcontracting plan threshold.

(10) A contracting officer may require a subcontracting plan if a firm's size status changes from small to other than small as a result of a size recertification.

(f) * * *

(2) All compliance reviews begin with a validation of the contractor's most recent ISR (or SF-294, if applicable) or SSR.

(i) A compliance review includes an evaluation of whether the prime contractor assigned the proper NAICS code and corresponding size standard to a subcontract, and a review of whether small business subcontractors qualify for the size or socioeconomic status claimed.

(ii) A compliance review includes validation of the contractor's methodology for completing its subcontracting reports.

(iii) A compliance review includes consideration of whether the contractor is monitoring its subcontractors with regard to their subcontracting plans, achievement of their proposed subcontracting goals, and reviewing their subcontractors' ISRs (or SF-294s, if applicable).

(g) Subcontracting consideration in source selection. (1) A solicitation requiring a subcontracting plan may contain an evaluation factor or subfactor for small business subcontracting participation in the subject procurement. A small business concern submitting an offer must receive the maximum score or credit under the evaluation factor or subfactor, without having to submit any information in connection with this factor or subfactor.

(2) When an ordering agency anticipates placing an order against a Federal Supply Schedule, government-wide acquisition contract (GWAC), or multi-agency contract (MAC), the ordering agency may evaluate subcontracting as a significant factor in its source selection process. In addition, the ordering agency may also evaluate subcontracting as a significant factor in source selection when entering into a blanket purchase agreement. At the time of contract award, the contracting officer must disclose to all competitors which one (or more) of these three elements will be evaluated as an important source selection evaluation factor in any subsequent procurement action. A small business offeror automatically receives the maximum possible score or credit on this evaluation factor without having to submit a subcontracting plan and without having to demonstrate subcontracting past performance. The factors that may be evaluated, individually or in combination, are:

We propose to adopt a new airworthiness directive (AD) for the products listed above that would supersede an existing AD. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

The right-hand inboard main landing gear (MLG) door of a CRJ 700 departed the aircraft during the landing phase of flight. The door damaged the trailing edge flap and punctured the rear fuselage near the floor level. The aircraft landed safely. Preliminary investigation indicates the failure was initiated by fatigue of the panel structure near a panel hinge lug. Loss of the main landing gear door during flight could result in damage to the aircraft and injury to persons on the ground.

The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI.DATES:

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2011-0994; Directorate Identifier 2010-NM-143-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

Since we issued AD 2006-14-05, Amendment 39-14676 (71 FR 38979, July 11, 2006), we have determined it is necessary to require a new modification of the MLG door configuration. We have also removed airplanes equipped with the new MLG door during production from the applicability of this NPRM. Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2003-23R3, dated May 21, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

The right-hand inboard main landing gear (MLG) door of a CRJ 700 departed the aircraft during the landing phase of flight. The door damaged the trailing edge flap and punctured the rear fuselage near the floor level. The aircraft landed safely. Preliminary investigation indicates the failure was initiated by fatigue of the panel structure near a panel hinge lug. Loss of the main landing gear door during flight could result in damage to the aircraft and injury to persons on the ground.

Subsequent to the issuance of Revision 1 of this directive, Transport Canada (TC) approved an alternate means of compliance (AMOC), AARDG 2004/A007, to allow extension of the repeat inspection interval when inboard MLG doors have incorporated certain repairs or modifications.

Subsequent to the issuance of the TC AMOC AARDG 2004/A007, an inboard MLG door departed from an aircraft operating under an AMOC equivalent to TC AMOC AARDG 2004/007. As a result of this incident, this directive was revised to Revision 2 to introduce additional inspection requirements according to Bombardier Alert Service Bulletin A670-32-016. In addition, Revision 2 also eliminated escalation of the repeat inspection interval allowed in TC AMOC AARDG 2004/007 and revised the aircraft applicability to add a new aircraft model.

Since the issuance of Revision 2 of this directive, TC approved an AMOC, AARDG 2006-A051, to allow the installation of a new modified MLG door configuration and to perform alternative inspection. Service history shows that this new modified MLG door configuration resolves the safety concerns associated with this directive.

Revision 3 of this directive mandates the incorporation of the new modified MLG door configuration in accordance with Bombardier Aerospace Service Bulletin (SB) 670BA-32-017 as the terminating action. In addition, this revision restricts the applicability to aircraft not equipped with the new modified MLG door configuration at delivery.

You may obtain further information by examining the MCAI in the AD docket.

We have also revised paragraph (j)(2) of this NPRM to remove reference to Task Cards 32-12-01-000-801-A01 and 32-12-01-400-801-A01 of the Bombardier CRJ 700/900 Series Regional Jet Aircraft Maintenance Manual. We added Note 2 to this NPRM to refer to these tasks cards as additional sources of guidance for replacing the lower panel assembly. Operators may contact the International Branch, ANM-116, Transport Airplane Directorate, FAA, for information regarding the use of the task cards for replacing the lower panel assembly, as required by paragraph (j)(2) of this AD.

Relevant Service Information

Bombardier has issued Alert Service Bulletin A670BA-32-016, Revision F, dated May 14, 2010, including Appendices A and B, dated June 2, 2005; and Service Bulletin 670BA-32-017, Revision C, dated May 14, 2010. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

Differences Between This AD and the MCAI or Service Information

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.

Costs of Compliance

Based on the service information, we estimate that this proposed AD would affect about 220 products of U.S. registry.

The actions that are required by AD 2006-14-05, Amendment 39-14676 (71 FR 38979, July 11, 2006), and retained in this proposed AD take about 3 work-hours per product, at an average labor rate of $85 per work hour. Based on these figures, the estimated cost of the currently required actions is $255 per product.

We estimate that it would take about 115 work-hours per product to comply with the new basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $0 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $2,150,500, or $9,775 per product.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

The right-hand inboard main landing gear (MLG) door of a CRJ 700 departed the aircraft during the landing phase of flight. The door damaged the trailing edge flap and punctured the rear fuselage near the floor level. The aircraft landed safely. Preliminary investigation indicates the failure was initiated by fatigue of the panel structure near a panel hinge lug. Loss of the main landing gear door during flight could result in damage to the aircraft and injury to persons on the ground.

Compliance

(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.

Restatement of Requirements of AD 2003-19-51, Amendment 39-13353 (68 FR 61615, October 29, 2003), With Revised Serial Numbers and Service InformationInitial Compliance Time

(g) For Model CL-600-2C10 (Regional Jet series 700 & 701) series airplanes, S/Ns 10003 through 10230 inclusive; and Model CL-600-2D24 (Regional Jet series 900) series airplanes, S/Ns 15002 through 15053 inclusive, 15055, and 15056: Perform the initial inspection specified in paragraph (h) of this AD at the applicable time specified in paragraph (g)(1) or (g)(2) of this AD.

(1) For airplanes with fewer than 1,500 total flight cycles as of November 3, 2003 (the effective date of AD 2003-19-51, Amendment 39-13353 (68 FR 61615, October 29, 2003)): Do the inspections before the accumulation of 1,050 total flight cycles, or within 50 flight cycles after August 15, 2006 (the effective date of AD 2006-14-05, Amendment 39-14676 (71 FR 38979, July 11, 2006)), whichever is later.

(2) For airplanes with 1,500 or more total flight cycles as of November 3, 2003: Do the inspections within 10 flight cycles after August 15, 2006.

Inspections

(h) For Model CL-600-2C10 (Regional Jet series 700 & 701) series airplanes, S/Ns 10003 through 10230 inclusive; and Model CL-600-2D24 (Regional Jet series 900) series airplanes, S/Ns 15002 through 15053 inclusive, 15055 and 15056: At the applicable time specified in paragraph (g) of this AD, perform detailed inspections of the lower panel, part number (P/N) CC670-10520, of the left- and right-hand MLG doors for the conditions and in the areas specified in paragraphs (h)(1), (h)(2), (h)(3), and (h)(4) of this AD; and Figures 1, 2, and 3 of this AD.

Note 1:

For the purposes of this AD, a detailed inspection is defined as: “An intensive visual examination of a specific structural area, system, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at intensity deemed appropriate by the inspector. Inspection aids such as mirror, magnifying lenses, etc., may be used. Surface cleaning and elaborate access procedures may be required.”

(1) Inspect the cross member, P/N CC670-10572, of the MLG door lower panel for cracking or deformation, in accordance with Figure 2 of this AD.

(2) Inspect the inner skin, P/N CC670-10577, of the MLG door lower panel at the cross member (P/N CC670-10572) for cracking or deformation, or pulled or missing fasteners, in accordance with Figure 2 of this AD.

(3) Inspect the outer skin, P/N CC670-10574, of the MLG door lower panel at the cross member (P/N CC670-10572) for cracking or deformation, or pulled or missing fasteners, in accordance with Figure 2 of this AD.

(4) Inspect the forward member, P/N CC670-10570, and aft member, P/N CC670-10571, of the MLG door lower panel for cracking or deformation, or pulled or missing fasteners, in accordance with Figure 3 of this AD. Figures 1 through 3 of this AD follow.

(i) If no cracking or deformation, or pulled or missing fastener, as applicable, is found during any inspection required by paragraph (h) or (i) of this AD, repeat the inspections thereafter at intervals not to exceed 100 flight cycles.

Corrective Actions

(j) If any cracking or deformation, or pulled or missing fastener, as applicable, is found during any inspection done in accordance with paragraph (h) or (i) of this AD: Before further flight, accomplish paragraph (j)(1), (j)(2), or (j)(3) of this AD.

(1) Repair the damage in accordance with a method approved by either the Manager, New York Aircraft Certification Office (ACO), FAA; or Transport Canada Civil Aviation (TCCA) (or its delegated agent); and accomplish repetitive inspections in accordance with a method and at a repetitive interval approved by same.

(2) Replace the lower panel assembly, P/N CC670-10520, of the affected MLG door with a new or serviceable lower panel assembly having the same P/N, according to a method approved by either the Manager, New York ACO, FAA; or TCCA (or its delegated agent). Repeat the inspections specified in paragraph (h) of this AD at intervals not to exceed 100 flight cycles.

Note 2:

For guidance on replacing the lower panel assembly, refer to Task Cards 32-12-01-000-801-A01 and 32-12-01-400-801-A01 of the Bombardier CRJ 700/900 Series Regional Jet Aircraft Maintenance Manual.

(3) Remove the lower panel assembly, P/N CC670-10520, of the affected MLG door, and accomplish paragraph (j)(3)(i) or (j)(3)(ii) of this AD, as applicable.

(i) For Model CL600-2C10 (Regional Jet series 700 & 701) series airplanes: Revise the Configuration Deviation List (CDL), Appendix 1, of the airplane flight manual (AFM), to include the following limitations. This may be accomplished by inserting a copy of this AD into the CDL of the AFM.

“For Model CL600-2C10 series airplanes: If one or both door panel assemblies, part number CC670-10520, is missing:

(1) Take-off Weight is reduced by 202.5 kg/door, or 450 lb/door.

(2) Enroute Climb Weight is reduced by 445.5 kg/door, or 990 lb/door.

(3) Landing Weight is reduced by 202.5 kg/door, or 450 lb/door.

(4) Fuel Consumption is increased by +3.42% on fuel used/door.

(5) Cruise Airspeed is limited to not more than 0.78 Mach.”

(ii) For Model CL-600-2D24 (Regional Jet series 900) series airplanes: Revise the CDL, Appendix 1, of the AFM, to include the following limitations. This may be accomplished by inserting a copy of this AD into the CDL of the AFM.

“For Model CL600-2D24 series airplanes: If one or both door panel assemblies, part number CC670-10520, is missing:

(k) For all airplanes on which an inspection has not been done in accordance with paragraph (h) of this AD on or before August 15, 2006: At the applicable time specified in paragraph (k)(1) or (k)(2) of this AD, do the inspections of the left- and right-hand inboard MLG doors for damage, in accordance with Part A of the Accomplishment Instructions of Bombardier Alert Service Bulletin A670BA-32-016, Revision A, dated June 7, 2005, excluding Appendix A, dated June 2, 2005, and including Appendix B, dated June 2, 2005; or Bombardier Alert Service Bulletin A670BA-32-016, Revision F, dated May 14, 2010, excluding Appendix A, dated June 2, 2005, and including Appendix B, dated June 2, 2005. Doing the inspections required by this paragraph terminates the actions required by paragraphs (g) through (j) of this AD. As of the effective date of this AD, use only Bombardier Alert Service Bulletin A670BA-32-016, Revision F, dated May 14, 2010.

(1) For airplanes that have accumulated fewer than 1,500 total flight cycles as of August 15, 2006: Before the accumulation of 1,000 total flight cycles, or within 50 flight cycles after August 15, 2006, whichever occurs later.

(2) For airplanes that have accumulated 1,500 flight cycles or more as of August 15, 2006: Within 10 flight cycles after August 15, 2006.

(l) For airplanes on which an inspection has been done in accordance with paragraph (h) of this AD on or before August 15, 2006: At the applicable time specified in paragraph (l)(1) or (l)(2) of this AD, inspect installed door(s) as specified in paragraph (k) of this AD. Doing the inspections required by this paragraph terminates the actions required by paragraphs (g) through (j) of this AD.

(1) For airplanes that are not subject to an approved alternative method of compliance (AMOC) that extends the inspection interval to 450 flight cycles: Within 100 flight cycles since the last inspection done in accordance with paragraph (h) of this AD.

(2) For airplanes that are subject to an approved AMOC that extends the inspection interval to 450 flight cycles: At the earlier of the times specified in paragraphs (l)(2)(i) and (l)(2)(ii) of this AD:

(i) Within 450 flight cycles since the last inspection done in accordance with paragraph (h) of this AD.

(ii) Within 100 flight cycles since the last inspection done in accordance with paragraph (h) of this AD, or within 50 cycles after August 15, 2006, whichever occurs later.

(m) If no damage is found during any inspection done in accordance with paragraph (k) of this AD, repeat the inspections specified in paragraph (k) of this AD thereafter at intervals not to exceed 100 flight cycles.

Corrective Action—Replace or Remove MLG Door

(n) If any damage is found during any inspection done in accordance with paragraph (k) of this AD, before further flight, do the actions in paragraph (n)(1) or (n)(2) of this AD. Repeat the inspections specified in paragraph (k) of this AD thereafter at intervals not to exceed 100 flight cycles.

(1) Replace the inboard MLG door with a new or repaired door in accordance with Part B of the Accomplishment Instructions of the Bombardier Alert Service Bulletin A670BA-32-016, Revision A, dated June 7, 2005, excluding Appendix A, dated June 2, 2005, and including Appendix B, dated June 2, 2005; or Bombardier Alert Service Bulletin A670BA-32-016, Revision F, dated May 14, 2010, excluding Appendix A, dated June 2, 2005, and including Appendix B, dated June 2, 2005; except where those service bulletins specify to contact the manufacturer for repair if no generic repair engineering order (REO) is available, before further flight, repair using a method approved by either the Manager, New York ACO, FAA; or TCCA (or its delegated agent). As of the effective date of this AD, use only Bombardier Alert Service Bulletin A670BA-32-016, Revision F, dated May 14, 2010.

(2) Remove the inboard MLG door in accordance with Part B of the Accomplishment Instructions of the Bombardier Alert Service Bulletin A670BA-32-016, Revision A, dated June 7, 2005, excluding Appendix A, dated June 2, 2005, and including Appendix B, dated June 2, 2005; or Bombardier Alert Service Bulletin A670BA-32-016, Revision F, dated May 14, 2010, excluding Appendix A, dated June 2, 2005, and including Appendix B, dated June 2, 2005; and accomplish paragraph (n)(2)(i) or (n)(2)(ii) of this AD, as applicable. As of the effective date of this AD, use only Bombardier Alert Service Bulletin A670BA-32-016, Revision F, dated May 14, 2010.

(i) For Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes and Model CL-600-2D15 (Regional Jet Series 705) airplanes: Revise the Configuration Deviation List (CDL), Appendix 1, of the Bombardier Canadair Regional Jet AFM, to include the following limitations. This may be accomplished by inserting a copy of this AD into the CDL of the AFM. Remove any existing CDL limitation required by paragraph (j)(3)(i) of this AD from the AFM.

“For Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes and Model CL-600-2D15 (Regional Jet Series 705) airplanes: If one or both door panel assemblies, part number CC670-10520, is missing:

(1) Take-off Weight is reduced by 202.5 kg/door, or 450 lb/door.

(2) Enroute Climb Weight is reduced by 445.5 kg/door, or 990 lb/door.

(3) Landing Weight is reduced by 202.5 kg/door, or 450 lb/door.

(4) Fuel Consumption is increased by +2.5% on fuel used/door.

(5) Cruise Airspeed is limited to not more than 0.78 Mach.

(6) The climb ceiling obtained from the Flight Planning and Cruise Control Manual (FPCCM) must be reduced by 1,000 ft/door.”

Note 3:

When a statement with the information specified in paragraph (n)(2)(i) of this AD has been included in the general revisions of the AFM, the general revisions may be inserted into the AFM, and the copy of this AD may be removed from the AFM.

(ii) For Model CL-600-2D24 (Regional Jet Series 900) airplanes: Revise the CDL, Appendix 1, of the Bombardier Canadair Regional Jet AFM, to include the following limitations. This may be accomplished by inserting a copy of this AD into the CDL of the AFM. Remove any existing CDL limitation required by paragraph (j)(3)(ii) of this AD from the AFM.

“For Model CL-600-2D24 (Regional Jet Series 900) airplanes: If one or both door panel assemblies, part number CC670-10520, is missing:

(1) Take-off Weight is reduced by 245 kg/door, or 540 lb/door.

(2) Enroute Climb Weight is reduced by 551 kg/door, or 1,215 lb/door.

(3) Landing Weight is reduced by 245 kg/door, or 540 lb/door.

(4) Fuel Consumption is increased by +2.5% on fuel used/door.

(5) Cruise Airspeed is limited to not more than 0.78 Mach.

(6) The climb ceiling obtained from the Flight Planning and Cruise Control Manual (FPCCM) must be reduced by 1,000 ft/door.”

Note 4:

When a statement with the information specified in paragraph (n)(2)(ii) of this AD has been included in the general revisions of the AFM, the general revisions may be inserted into the AFM, and the copy of this AD may be removed from the AFM.

Revise CDL

(o) For airplanes on which the door(s) have been removed in accordance with paragraph (j)(3) of this AD: Within 30 days after August 15, 2006, do the revision specified in paragraph (n)(2)(i) or (n)(2)(ii) of this AD, as applicable, and remove any revision required by paragraph (j)(3)(i) or (j)(3)(ii) of this AD.

No Reporting Required

(p) Although Bombardier Alert Service Bulletin A670BA-32-016, Revision A, dated June 7, 2005, excluding Appendix A, dated June 2, 2005, and including Appendix B, dated June 2, 2005; and Revision F, dated May 14, 2010, excluding Appendix A, dated June 2, 2005, and including Appendix B, dated June 2, 2005; specify to submit certain information to the manufacturer, this AD does not include that requirement.

Actions Accomplished According to Previous Issue of Service Bulletin

(q) Actions accomplished before August 15, 2006, according to Bombardier Alert Service Bulletin A670BA-32-016, dated June 2, 2005, are considered acceptable for compliance with the corresponding actions of this AD.

New Requirements of This ADTerminating Modification for MLG Door Configuration

(r) Within 6,000 flight hours after the effective date of this AD, modify the MLG door, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 670BA-32-017, Revision C, dated May 14, 2010. Doing this modification terminates the requirements of this AD.

Credit for Actions Accomplished in Accordance With Previous Service Information

(s) Modifying the MLG door before the effective date of this AD, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 670BA-32-017, dated July 24, 2006; Revision A, dated September 26, 2006; or Revision B, dated July 31, 2008; as applicable; is considered acceptable for compliance with the requirements of paragraph (r) of this AD.

FAA AD DifferencesNote 5:

This AD differs from the MCAI and/or service information as follows: No differences.

Other FAA AD Provisions

(t) The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO, ANE-170, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to Attention: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone 516-228-7300; fax 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD. AMOCs approved previously in accordance with AD 2006-14-05, Amendment 39-14676 (71 FR 38979, July 11, 2006), are acceptable for compliance with this AD.

(2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

Based on in-service experience, the System Safety Analyses for the Flight Controls have been reviewed and their conclusions have been accepted during the latest Candidate Maintenance Coordination Committee meeting.

This review resulted in reduced inspection intervals, specifically for the flight controls tab-to-actuator linkage [certification maintenance requirements] CMR** repetitive inspections, which have been identified as mandatory actions for continued airworthiness.

Failure of these components or their constituent parts could lead to reduced control of the aeroplane.

The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI.DATES:

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2011-0995; Directorate Identifier 2010-NM-243-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2010-0054, dated March 25, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Based on in-service experience, the System Safety Analyses for the Flight Controls have been reviewed and their conclusions have been accepted during the latest Candidate Maintenance Coordination Committee meeting.

This review resulted in reduced inspection intervals, specifically for the flight controls tab-to-actuator linkage CMR** repetitive inspections, which have been identified as mandatory actions for continued airworthiness.

Failure of these components or their constituent parts could lead to reduced control of the aeroplane.

Consistent with the EASA policy to require compliance with any new and reduced airworthiness limitations by taking AD action and for the reasons described above, this EASA AD requires the accomplishment of the reduced-interval repetitive inspections and, depending on findings, related corrective action(s). In addition, this AD requires the implementation of the affected reduced inspection intervals and associated corrective actions into the operator's approved maintenance programme.

You may obtain further information by examining the MCAI in the AD docket.Relevant Service Information

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

Differences Between This AD and the MCAI or Service Information

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.

Costs of Compliance

Based on the service information, we estimate that this proposed AD would affect about 63 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $5,355, or $85 per product.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

Based on in-service experience, the System Safety Analyses for the Flight Controls have been reviewed and their conclusions have been accepted during the latest Candidate Maintenance Coordination Committee meeting.

This review resulted in reduced inspection intervals, specifically for the flight controls tab-to-actuator linkage [certification maintenance requirements] CMR** repetitive inspections, which have been identified as mandatory actions for continued airworthiness.

Failure of these components or their constituent parts could lead to reduced control of the aeroplane.

Compliance

(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.

Maintenance Program Revision

(g) Within 100 flight hours after the effective date of this AD: Revise the airplane maintenance program by incorporating the applicable CMR tasks identified in table 1 of this AD.

(h) The initial compliance time for the CMR tasks identified in table 1 of this AD is within 500 flight hours after the most recent inspection, or within 100 flight hours after the effective date of this AD, whichever occurs later.

No Alternative Inspections or Inspection Intervals

(i) After accomplishing the revision required by paragraph (g) of this AD, no alternative inspection or inspection interval may be used unless the inspection or inspection interval is approved as an alternative methods of compliance (AMOC) in accordance with the procedures specified in paragraph (j) of this AD.

FAA AD DifferencesNote 1:

This AD differs from the MCAI and/or service information as follows:

Although EASA Airworthiness Directive 2010-0054, dated March 25, 2010, specifies both revising the maintenance program, doing certain repetitive actions, and doing corrective actions, this AD only requires the revision. Requiring a revision of the maintenance program, rather than requiring individual repetitive actions, requires operators to record AD compliance only at the time the revision is made.

Other FAA AD Provisions

(j) The following provisions also apply to this AD:

(1) Alternative Methods of Compliance: The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to Attn: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425) 227-1137; fax (425) 227-1149. Information may be e-mailed to: 9-ANM-116-AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

(2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

Cases of corrosion findings have been reported on the overwing refueling aperture (used to fill the fuel tank by gravity) on the wing top skin. * * *

This condition, if not corrected, could, in combination with a lightning strike in this area, create a source of ignition in a fuel tank, possibly resulting in a fire or explosion and consequent loss of the aeroplane.

The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI.DATES:

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2011-0998; Directorate Identifier 2011-NM-046-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2011-0034, dated March 2, 2011 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Cases of corrosion findings have been reported on the overwing refueling aperture (used to fill the fuel tank by gravity) on the wing top skin. The reported corrosion was on the mating surface of the aperture flange, underneath the refuel adaptor. Corrosion findings have been repaired on a case by case basis in accordance with approved data.

For certain aeroplanes (identified by MSN in the applicability section of this AD), the provided repair contained instructions to apply primer coating on the mating surface. Since doing those repairs, it has been found that this primer coating may prevent proper electrical bonding provision between the overwing refuelling cap adaptor and the wing skin.

This condition, if not corrected, could, in combination with a lightning strike in this area, create a source of ignition in a fuel tank, possibly resulting in a fire or explosion and consequent loss of the aeroplane.

For the reasons described above, this AD requires a one-time electrical bonding check between the gravity fill re-fuel adaptor and the top skin panels on the affected aeroplanes and, in case of findings [a general visual inspection for corrosion of the component interface and adjacent area], the application of the associated corrective actions [i.e. repair].

You may obtain further information by examining the MCAI in the AD docket.Relevant Service Information

Airbus has issued Service Bulletin A320-57-1152, dated June 14, 2010. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

Differences Between This AD and the MCAI or Service Information

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.

Costs of Compliance

Based on the service information, we estimate that this proposed AD would affect about 67 products of U.S. registry. We also estimate that it would take about 6 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $34,170 or $510 per product.

In addition, we estimate that any necessary follow-on actions would take about 6 work-hours and require parts costing $0, for a cost of $510 per product. We have no way of determining the number of products that may need these actions.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

Cases of corrosion findings have been reported on the overwing refueling aperture (used to fill the fuel tank by gravity) on the wing top skin. * * *

This condition, if not corrected, could, in combination with a lightning strike in this area, create a source of ignition in a fuel tank, possibly resulting in a fire or explosion and consequent loss of the aeroplane.

Compliance

(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.

Actions

(g) Within 24 months after the effective date of this AD, do an electrical bonding test to check for bonding between the re-fuel adaptor of the gravity fill and the top skin panels on the left-hand and right-hand wings, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1152, dated June 14, 2010.

(1) If the resistance value is 10 milliOhms or less at the left-hand and right-hand wing, no further action is required.

(2) If the resistance value is greater than 10 milliOhms at the left-hand or right-hand wing, before further flight do a general visual inspection for corrosion of the component interface and adjacent area, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1152, dated June 14, 2010. If any corrosion is found during the inspection, before further flight repair the gravity fuel adaptor, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1152, dated June 14, 2010; except where Airbus Service Bulletin A320-57-1152, dated June 14, 2010, specifies to contact Airbus before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA) (or its delegated agent).

FAA AD DifferencesNote 1:

This AD differs from the MCAI and/or service information as follows: No differences.

Other FAA AD Provisions

(h) The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425) 227-1405; fax (425) 227-1149. Information may be e-mailed to: 9-ANM-116-AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

(2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD would require replacement of the thumbnail fairing edge seals on both sides of the engines with Nitronic 60 stainless steel alloy seals. This proposed AD was prompted by reports of excessive in-service wear damage of the thumbnail fairing edge seal and the fan cowl panel rub strip and fan cowl skin assembly. We are proposing this AD to prevent failure of the fire seal, which could allow a fire in the fan compartment to spread beyond the firewall and reach the flammable fluid leakage zones, resulting in an uncontrolled fire.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2011-0996; Directorate Identifier 2011-NM-068-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

Discussion

We received reports of repetitive occurrences of excessive in-service wear damage of the thumbnail fairing edge seal and of the fan cowl panel rub strip and fan cowl skin assembly. Identical abrasion damage was also reported at the location where the thumbnail fairing edge seal rests against the top surface of the hinge beam forward firewall. This condition, if not corrected, could result in failure of the fire seal, which could allow a fire in the fan compartment to spread beyond the firewall and reach the flammable fluid leakage zones, resulting in an uncontrolled fire.

Relevant Service Information

We reviewed Boeing Special Attention Service Bulletin 737-54-1046, dated February 16, 2011. That service bulletin describes procedures for replacing the thumbnail fairing edge seals on both the left side and the right side of both engine 1 and engine 2 with new Nitronic 60 stainless steel alloy seals.

FAA's Determination and Proposed AD Requirements

We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs. This proposed AD would require accomplishing the actions specified in the service information described previously.

Costs of Compliance

We estimate that this proposed AD affects 989 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

(c) This AD applies to The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes, certificated in any category, as identified in Boeing Special Attention Service Bulletin 737-54-1046, dated February 16, 2011.

(e) This AD was prompted by reports of excessive in-service wear damage of the thumbnail fairing edge seal and the fan cowl panel rub strip and fan cowl skin assembly. We are issuing this AD to prevent failure of the fire seal, which could allow a fire in the fan compartment to spread beyond the firewall and reach the flammable fluid leakage zones, resulting in an uncontrolled fire.

Compliance

(f) Comply with this AD within the compliance times specified, unless already done.

Replacement of the Thumbnail Fairing Edge Seals

(g) Within 60 months after the effective date of this AD, replace the thumbnail fairing edge seals, on both the left side and the right side of engine 1 and engine 2, with new Nitronic 60 stainless steel alloy seals, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-54-1046, dated February 16, 2011.

Alternative Methods of Compliance (AMOCs)

(h)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in the Related Information section of this AD. Information may be e-mailed to: 9-ANM-Seattle-ACO-AMOC-Requests@faa.gov.

(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

During fatigue testing of the MLG [main landing gear], three failures of the retraction bracket occurred before the calculated life limitation. Further analysis has confirmed that those failures were due to fatigue initiated by fretting between the bush and lug bore.

The failure of the retraction bracket, if not detected, could lead to a MLG extension with no damping resulting in MLG structural damage.

The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2011-0997; Directorate Identifier 2011-NM-043-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2010-0205, dated October 8, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

During fatigue testing of the MLG [main landing gear], three failures of the retraction bracket occurred before the calculated life limitation. Further analysis has confirmed that those failures were due to fatigue initiated by fretting between the bush and lug bore.

The failure of the retraction bracket, if not detected, could lead to a MLG extension with no damping resulting in MLG structural damage.

Airbus carried out an investigation, demonstrating that the life limit of retraction brackets must be reduced to 19,800 Landings (LDG), which is below the life limit stated in the following A330 and A340 Airbus ALS Part 4 revisions:

In order to maintain the structural integrity of the aeroplane, this [EASA] AD requires the replacement of these MLG retraction brackets before the accumulation of 19,800 total LDG.

You may obtain further information by examining the MCAI in the AD docket.

FAA's Determination and Requirements of This Proposed AD

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

Differences Between This AD and the MCAI or Service Information

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.

Costs of Compliance

Based on the service information, we estimate that this proposed AD would affect about 29 products of U.S. registry. We also estimate that it would take about 25 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $200,000 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $5,861,625, or $202,125 per product.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

(c) This AD applies to Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212, -213, -311, -312, and -313 airplanes; certificated in any category, all manufacturer serial numbers; except airplanes on which Airbus modification 54500 has been embodied in production; and except airplanes on which Airbus Service Bulletin A330-32-3212 or Airbus Service Bulletin A340-32-4256 has been embodied in service; as applicable to airplane model.

Subject

(d) Air Transport Association (ATA) of America Code 32: Landing Gear.

Reason

(e) The mandatory continuing airworthiness information (MCAI) states:

During fatigue testing of the MLG [main landing gear], three failures of the retraction bracket occurred before the calculated life limitation. Further analysis has confirmed that those failures were due to fatigue initiated by fretting between the bush and lug bore.

The failure of the retraction bracket, if not detected, could lead to a MLG extension with no damping resulting in MLG structural damage.

Compliance

(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.

Actions

(g) Before the accumulation of 19,800 total landings on the retraction brackets of the main landing gear or within 900 flight hours after the effective date of this AD, whichever occurs later: Replace the affected retraction bracket of the MLG specified in table 1 of this AD with a serviceable part, in accordance with a method approved by the Manager, International Branch, ANM-116, FAA, or European Aviation Safety Agency (EASA) (or its delegated agent). Thereafter, before the accumulation of 19,800 total landings on any retraction bracket of the MLG identified in table 1 of this AD, replace the retraction bracket with a serviceable part, in accordance with a method approved by the Manager, International Branch, ANM-116, FAA, or EASA (or its delegated agent).

Table 1—Retraction Bracket of the MLGNomenclaturePart Nos.Retraction Bracket of the MLG201478303201478304201478305201478306201478307201478308201428380201428381201428382201428383201428384201428385201428378201428379201428351201428352Note 1:

Additional guidance for the replacement can be found in Task 32-11-11-400-804-A, Removal of the MLG Retraction Bracket Assembly, and Task 32-11-11-000-804-A, Installation of the MLG Retraction Bracket Assembly, of subsection 32-11-11 of Chapter 32 of the Airbus A330 Aircraft Maintenance Manual, Revision 36, dated January 1, 2011.

Note 2:

“Total landings” are the accumulated landings since the initial entry of the MLG retraction bracket into service on any airplane.

Note 3:

The initial entry into service for the transferable systems components/items is defined as the date at which the component/item accomplishes the first flight for which it will undertake its intended function.

FAA AD DifferencesNote 4:

This AD differs from the MCAI and/or service information as follows: No differences.

Other FAA AD Provisions

(h) The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425) 227-1138; fax (425) 227-1149. Information may be e-mailed to: 9-ANM-116-AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

(2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

DATES:

Comments must be received on or before November 4, 2011.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:

Instructions: Direct your comments to the docket ID number and the pesticide petition number of interest as shown in the body of this document. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:

A contact person, with telephone number and e-mail address, is listed at the end of each pesticide petition summary. You may also reach each contact person by mail at Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:I. General InformationA. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed at the end of the pesticide petition summary of interest.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

II. What action is the Agency taking?

EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 174 or part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain the data or information prescribed in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on these pesticide petitions.

Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that are the subject of this document, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available on-line at http://www.regulations.gov.

As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.

New Tolerances

1. PP 1E7890. (EPA-HQ-OPP-2011-0758). Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201-W., Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180 for residues of the herbicide sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]-methanesulfonamide) and its metabolites 3-hydroxymethyl-sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide), in or on rhubarb at 0.2 parts per million (ppm); turnip, roots at 0.2 ppm; turnip, tops at 0.7 ppm; and sunflower subgroup 20B at 0.2 ppm; “Tolerances with regional registrations” in or on wheat, forage at 0.45 ppm (Pacific Northwest only); wheat, hay at 0.20 ppm (Pacific Northwest only); wheat, grain at 0.20 ppm (Pacific Northwest only); wheat, straw at 1.4 ppm (Pacific Northwest only); and cowpea, succulent at 0.15 ppm (Tennessee only). There is a practical analytical method for detecting and measuring levels of sulfentrazone and its metabolites in or on food with a limit of quantitation that allows monitoring of food with residues at or above the levels set or proposed in the tolerances. The analytical enforcement method for sulfentrazone was used with minor modification that eliminated several clean-up and derivatization steps that was required for gas chromatography with mass selective detection (GC/MSD) but not for liquid chromatography with tandem mass spectrometric detection (LC/MS/MS). The analytical method for sulfentrazone involves separate analyses for parent and its metabolites. The parent is analyzed by evaporation and reconstitution of the sample prior to analysis by LC/MS/MS GC/electron capture detector (ECD). The metabolites samples were refluxed in the presence of acid and cleaned up with solid phase extraction prior to analysis by LC/MS/MS. Contact: Laura Nollen, (703) 305-7390, e-mail address: nollen.laura@epa.gov.

2. PP 1F7872. (EPA-HQ-OPP-2011-0743). Agriphar S.A., c/o Ceres International, LLC., 1087 Heartsease Drive, West Chester, PA 19382, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide dodine (dodecylguanidine acetate), in or on stone fruits (Group 12) at 5 parts per million (ppm); tree nuts (Group 14, except almond hulls) at 0.3 ppm; and almond hulls at 12 ppm. An adequate enforcement method using GC/mass spectrometry detection (MSD), Method 45137, is available for determining dodine residues in or on plant commodities. Concerning tree crops, a method using LC/MS/MS; METH1595.02, after the samples were extracted with methanol, was submitted. Adequate data collection method validation, independent laboratory validation (ILV), and radio-validation data for the method has been submitted. Since there is no reasonable expectation of finding residues of dodine in livestock or poultry, no analytical method for animal tissues is required. Contact: Tamue L. Gibson, (703) 305-9096, e-mail address: gibson.tamue@epa.gov.

3. PP 1F7887. (EPA-HQ-OPP-2011-0741). Cytec Industries, Inc., 5 Garret Mountain Plaza, Woodland Park, NJ 07424, requests to establish tolerances in 40 CFR part 180 for residues of phosphine, in or on asparagus; cherimoya; dates, fresh; figs, fresh; globe artichokes; pawpaws; pineapple, water chestnuts and watercress, and for all fresh fruit and vegetable crop groups (including berry and small fruit; citrus fruit; pome fruit; stone fruit; herbs and spices; Brassica leafy vegetables; leafy vegetables; bulb vegetables; cucurbits; fruiting vegetables except cucurbits; legume vegetables, except soybeans; foliage of legume vegetables; root and tuber group; and root and tuber leaves group) at 0.01 ppm. The PAM Vol. II lists, under aluminum phosphide, a colorimetric method level of detection (LOD = 0.01) and a gas liquid chromatography (GLC) method with a flame photometric detection (LOD = 0.001 ppm) as Method A and B, respectively, for the enforcement of tolerances. The residue of concern is phosphine. It is noted that Method A, remains a lettered method because of variable recoveries observed in an Agency method try-out. However, the method has been determined to be acceptable for enforcement because phosphine is highly reactive, and finite residues are not expected. Data submitted in support of the established tolerances were collected by one of these two methods. Because phosphine is an inorganic compound, recovery of residues using FDA Multiresidue Protocols is not expected, and the requirement for such data has been waived by the Agency. Contact: Gene Benbow, (703) 347-0235, e-mail address: benbow.gene@epa.gov.

PP 1E7890. (EPA-HQ-OPP-2011-0758). Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201-W., Princeton, NJ 08540, requests to amend the current tolerances in 40 CFR 180.498 for residues of the herbicide sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]-methanesulfonamide) and its metabolites 3-hydroxymethyl-sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide), in or on bean, lima, succulent at 0.15 ppm by removing the tolerance from the table in Section (a)(2) and adding the tolerance to Section (c) Tolerances with regional registrations. Upon approval of the aforementioned tolerance under “New Tolerances”, the petition additionally proposes to remove the established tolerance in or on the raw agricultural commodity sunflower, seed at 0.2 ppm. Contact: Laura Nollen, (703) 305-7390, e-mail address: nollen.laura@epa.gov.

New Tolerance Exemptions

1. PP 1E7903. (EPA-HQ-OPP-2011-0736). ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077, requests to establish an exemption from the requirement of a tolerance for residues of D-mannose (CAS No. 3458-28-4) under 40 CFR 180.920 when used as an inert ingredient (sequestrant) in pesticide formulations applied pre-harvest to all raw agricultural commodities. The petitioner believes no analytical method is needed because this information is not required for the establishment of a tolerance exemption. Contact: Mark Dow, (703) 305-5533, e-mail address: dow.mark@epa.gov.

2. PP 1E7909. (EPA-HQ-OPP-2011-0732). Momentive Performance Materials, 22 Corporate Woods Blvd., Albany, NY 12211, requests to establish an exemption from the requirement of a tolerance for residues of 2-Propenoic acid, 2-methyl-, polymer with butyl 2-propenoate and ethenylbenzene (CAS No. 25036-16-2) under 40 CFR 180.960 when used as a pesticide inert ingredient as a sticker in pesticide formulations without limitation. The petitioner believes no analytical method is needed because this information is not required for the establishment of a tolerance exemption. Contact: Elizabeth Fertich, (703) 347-8560, e-mail address: fertich.elizabeth@epa.gov.

Comments are requested on the proposed Base (1% annual-chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this proposed rule is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.

DATES:

Comments are to be submitted on or before January 3, 2012.

ADDRESSES:

The corresponding preliminary Flood Insurance Rate Map (FIRM) for the proposed BFEs for each community is available for inspection at the community's map repository. The respective addresses are listed in the table below.

The Federal Emergency Management Agency (FEMA) proposes to make determinations of BFEs and modified BFEs for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

These proposed BFEs and modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These proposed elevations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in those buildings.

Comments on any aspect of the Flood Insurance Study and FIRM, other than the proposed BFEs, will be considered. A letter acknowledging receipt of any comments will not be sent.

National Environmental Policy Act. This proposed rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Executive Order 12866, Regulatory Planning and Review. This proposed rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866, as amended.

Executive Order 13132, Federalism. This proposed rule involves no policies that have federalism implications under Executive Order 13132.

2. The tables published under the authority of § 67.4 are proposed to be amended as follows:

StateCity/town/countySource of floodingLocation *** Elevation in feet

(NGVD)

+ Elevation in feet

(NAVD)

# Depth in feet above ground

⁁ Elevation in meters (MSL)

ExistingModifiedUnincorporated Areas of Carbon County, MontanaMontanaUnincorporated Areas of Carbon CountyClarks Fork Yellowstone RiverApproximately 1.89 miles downstream of Twany TrailNone+3304Approximately 770 feet downstream of the Rock Creek (Lower) confluenceNone+3405* National Geodetic Vertical Datum.+ North American Vertical Datum.# Depth in feet above ground.⁁ Mean Sea Level, rounded to the nearest 0.1 meter.** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472.ADDRESSESUnincorporated Areas of Carbon CountyMaps are available for inspection at 17 West 11th Street, Red Lodge, MT 59068.Unincorporated Areas of Mineral County, NevadaNevadaUnincorporated Areas of Mineral CountyCottonwood CreekApproximately 1,400 feet north of the intersection of Marian Drive and U.S. Route 95None#1NevadaUnincorporated Areas of Mineral CountyMina FanApproximately 1,584 feet southwest of the intersection of Cross Street and U.S. Route 95None#1Approximately 1.8 miles southwest of the intersection of 1st Street and U.S. Route 95None#1Approximately 2.0 miles southwest of the intersection of Cross Street and U.S. Route 95None#1Approximately 0.7 mile upstream of the intersection of 1st Street and U.S. Route 95None#1* National Geodetic Vertical Datum.+ North American Vertical Datum.# Depth in feet above ground.⁁ Mean Sea Level, rounded to the nearest 0.1 meter.** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472.ADDRESSESUnincorporated Areas of Mineral CountyMaps are available for inspection at 105 South A Street, Suite 1, Hawthorne, NV 89415.City of Lubbock, TexasTexasCity of LubbockPlaya System E1At the intersection of Avenue T and 40th Street+3208+3206At the intersection of Slide Road and 58th Street+3255+3256* National Geodetic Vertical Datum.+ North American Vertical Datum.# Depth in feet above ground.⁁ Mean Sea Level, rounded to the nearest 0.1 meter.** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.ADDRESSESCity of LubbockMaps are available for inspection at City Hall, 1625 13th Street, Lubbock, TX 79401.City of McCleary, WashingtonWashingtonCity of McClearyEast Fork Wildcat CreekApproximately 360 feet upstream of State Route 108None+245Approximately 1,200 feet upstream of the railroadNone+268* National Geodetic Vertical Datum.+ North American Vertical Datum.# Depth in feet above ground.⁁ Mean Sea Level, rounded to the nearest 0.1 meter.** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.ADDRESSESCity of McCleary* Maps are available for inspection at City Hall, 100 South 3rd Street, McCleary, WA 98557.Flooding source(s)Location of referenced elevation***Elevation in feet (NGVD)

+Elevation in feet

(NAVD)

#Depth in feet

above ground

⁁Elevation in meters (MSL)

Effective ModifiedCommunities affectedVolusia County, Florida, and Incorporated AreasB-19 CanalAt the Spruce Creek confluence+4+5City of Daytona Beach, City of Port Orange, Unincorporated Areas of Volusia County.Approximately 375 feet upstream of Beville RoadNone+29B-27 Canal NorthAt the LPGA Canal confluenceNone+5City of Holly Hill, Unincorporated Areas of Volusia County.Approximately 75 feet upstream of Calle Grande StreetNone+5B-27 Canal SouthAt the LPGA Canal confluenceNone+5City of Daytona Beach, City of Holly Hill.Approximately 70 feet upstream of Kingston AvenueNone+6Halifax CanalApproximately 700 feet upstream of Powers AvenueNone+6City of Port Orange.Approximately 100 feet upstream of Jackson StreetNone+7LPGA CanalAt the upstream side of Ridgewood AvenueNone+4City of Holly Hill.Approximately 1,940 feet upstream of Center AvenueNone+7Laurel CreekAt the upstream side of the railroadNone+6City of Ormond Beach.Approximately 330 feet upstream of Laurel Oaks CircleNone+7Nova Canal North Reach 1Approximately 775 feet downstream of LPGA BoulevardNone+7City of Holly Hill, Unincorporated Areas of Volusia County.At the upstream side of Alabama AvenueNone+7Nova Canal North Reach 2Approximately 1,660 feet downstream of 10th StreetNone+7City of Daytona Beach, City of Holly Hill.Approximately 925 feet upstream of Orange AvenueNone+8Nova Canal South Reach 1Approximately 125 feet downstream of Reed Canal RoadNone+7City of Daytona Beach, City of South Daytona.At the Nova Canal North Reach 2 confluenceNone+8Nova Canal South Reach 2Approximately 1,775 feet upstream of Nova RoadNone+7City of Port Orange, City of South Daytona.At the Nova Canal South Reach 1 confluenceNone+7Thompson CreekAt the upstream side of Industrial Drive+6+7City of Ormond Beach.Approximately 575 feet upstream of Division AvenueNone+8* National Geodetic Vertical Datum.+ North American Vertical Datum.# Depth in feet above ground.⁁ Mean Sea Level, rounded to the nearest 0.1 meter.** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.ADDRESSESCity of Daytona BeachMaps are available for inspection at 950 Bellevue Avenue, Room 600, Daytona Beach, FL 32115.City of Holly HillMaps are available for inspection at 1065 Ridgewood Avenue, Holly Hill, FL 32117.City of Ormond BeachMaps are available for inspection at 22 South Beach Street, Ormond Beach, FL 32174.City of Port OrangeMaps are available for inspection at 1000 City Center Circle, Port Orange, FL 32129.City of South DaytonaMaps are available for inspection at 1672 South Ridgewood Avenue, South Daytona, FL 32119.Unincorporated Areas of Volusia CountyMaps are available for inspection at 123 West Indiana Avenue, DeLand, FL 32720.Webster County, Iowa, and Incorporated AreasDes Moines RiverApproximately 1.6 miles downstream of U.S. Route 20None+987City of Fort Dodge, Unincorporated Areas of Webster County.Approximately 2.1 miles upstream of East Hawkeye AvenueNone+1008Lizard CreekAt the Des Moines River confluence+992+995City of Fort Dodge, Unincorporated Areas of Webster County.Approximately 0.9 mile upstream of Phinney Park Drive+1000+999Soldier CreekAt the Des Moines River confluenceNone+993City of Fort Dodge, Unincorporated Areas of Webster County.Approximately 1.2 miles upstream of Soldier Creek DriveNone+1098* National Geodetic Vertical Datum.+ North American Vertical Datum.# Depth in feet above ground.⁁ Mean Sea Level, rounded to the nearest 0.1 meter.** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.ADDRESSESCity of Fort DodgeMaps are available for inspection at 819 1st Avenue South, Fort Dodge, IA 50501.Unincorporated Areas of Webster CountyMaps are available for inspection at the Webster County Courthouse, 701 Central Avenue, 4th Floor, Fort Dodge, IA 50501.St. Helena Parish, Louisiana, and Incorporated AreasJoseph BranchApproximately 0.70 mile upstream of Kendrick RoadNone+189Unincorporated Areas of St. Helena Parish.Approximately 0.90 mile upstream of Kendrick RoadNone+189Ward Line CanalApproximately 790 feet upstream of Sitman RoadNone+185Town of Greensburg.Approximately 1,480 feet upstream of Sitman RoadNone+187* National Geodetic Vertical Datum. North American Vertical Datum.# Depth in feet above ground.⁁ Mean Sea Level, rounded to the nearest 0.1 meter.** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.ADDRESSESTown of GreensburgMaps are available for inspection at the Town Hall, 14560 Louisiana Highway 37, Greensburg, LA 70441Unincorporated Areas of St. Helena ParishMaps are available for inspection at the St. Helena Parish Police Jury Administration Building, 17911 Louisiana Highway 43, Greensburg, LA 70441.Oceana County, Michigan (All Jurisdictions)Lake MichiganEntire shoreline within communityNone+585Township of Benona, Township of Claybanks.Lake MichiganEntire shoreline within communityNone+584Township of Golden.Pentwater LakeEntire shorelineNone+584Township of Weare.* National Geodetic Vertical Datum.+ North American Vertical Datum.# Depth in feet above ground.⁁ Mean Sea Level, rounded to the nearest 0.1 meter.** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.ADDRESSESTownship of BenonaMaps are available for inspection at the Benona Township Hall, 7169 West Baker Road, Shelby, MI 49455.Township of ClaybanksMaps are available for inspection at the Claybanks Township Hall, 7577 West Cleveland Road, New Era, MI 49446.Township of GoldenMaps are available for inspection at the Golden Township Hall, 5527 West Fox Road, Mears, MI 49436.Township of WeareMaps are available for inspection at the Weare Township Hall, 5846 North Oceana Drive, Hart, MI 49420.Fort Bend County, Texas, and Incorporated AreasBrazos RiverApproximately 2.16 miles downstream of FM 2759+62+61Town of Thompsons.Approximately 2.75 miles upstream of the Alcorn Bayou confluenceNone+71Oyster CreekApproximately 1.1 miles downstream of FM 1464None+81Fort Bend County Municipal Utility District No. 25.Approximately 150 feet downstream of FM 1464None+81* National Geodetic Vertical Datum.+ North American Vertical Datum.# Depth in feet above ground.⁁ Mean Sea Level, rounded to the nearest 0.1 meter.** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.ADDRESSESFort Bend County Municipal Utility District No. 25Maps are available for inspection at 8522 Katy Freeway, Suite 300, Houston, TX 77024.Town of ThompsonsMaps are available for inspection at 520 Thompson Oil Field Road, Thompsons, TX 77481.Montgomery County, Texas, and Incorporated AreasArnold BranchApproximately 1.4 miles downstream of FM 1488None+219Town of Magnolia.Approximately 1,475 feet upstream of FM 1488None+246Peach CreekApproximately 1,375 feet downstream of Roman Forest BoulevardNone+85Town of Roman Forest.Approximately 425 feet upstream of Roman Forest BoulevardNone+86* National Geodetic Vertical Datum.+ North American Vertical Datum.# Depth in feet above ground.⁁ Mean Sea Level, rounded to the nearest 0.1 meter.** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472.ADDRESSESTown of MagnoliaMaps are available for inspection at 510 Magnolia Boulevard, Magnolia, TX 77356.Town of Roman ForestMaps are available for inspection at 2430 Roman Forest Boulevard, New Caney, TX 77357.(Catalog of Federal Domestic Assistance No. 97.022, “Flood Insurance.”)Dated: September 13, 2011.Sandra K. Knight,Deputy Associate Administrator for Mitigation,Department of Homeland Security,Federal Emergency Management Agency.[FR Doc. 2011-25611 Filed 10-4-11; 8:45 am]BILLING CODE 9110-12-PFEDERAL COMMUNICATIONS COMMISSION47 CFR Part 15[ET Docket No. 10-26; FCC 11-133]Definition of Part 15 Auditory Assistance DeviceAGENCY:

Federal Communications Commission.

ACTION:

Proposed rule.

SUMMARY:

This document proposes to amend the definition of “auditory assistance device” in the Commission's rules to allow such devices to be used by anyone at any location for simultaneous language interpretation, where the spoken words are translated continuously in near real time. This action is taken in response to a petition for declaratory ruling filed by Williams Sound Corporation (Williams Sound Petition), a provider of wireless auditory assistance devices. The current definition restricts the use of part 15 auditory assistance devices that operate in the 72.0-73.0 MHz, 74.6-74.8 MHz, and 75.2-76.0 MHz bands (72-76 MHz bands) to auditory assistance to a handicapped person or persons; such devices may be used for auricular training in an educational institution, for auditory assistance at places of public gatherings, such as a church, theater, or auditorium, and to handicapped individuals, only, in other locations. The proposed amendment would permit part 15 auditory assistance devices that operate in the 72-76 MHz bands to be used by anyone at any location for simultaneous language interpretation.

DATES:

Comments must be filed on or before November 4, 2011, and reply comments must be filed on or before November 21, 2011.

For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION of this document.SUPPLEMENTARY INFORMATION:

This is a summary of the Commission's Order and Notice of Proposed Rule Making, ET Docket No. 10-26, FCC 11-133, adopted September 9, 2011, and released September 16, 2011. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at: http://www.fcc.gov.

Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

• Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: http://fjallfoss.fcc.gov/ecfs2/.

• Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

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People With Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an e-mail to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

Introduction

1. In the Notice of Proposed Rule Making (NPRM), the Commission proposes to amend the definition of “auditory assistance device” in its part 15 rules to allow such devices to be used by anyone at any location for simultaneous language interpretation, where the spoken words are translated continuously in near real time. Auditory assistance devices transmit audio signals via radio frequency (RF) waves, magnetic fields, or infrared light waves to specialized receivers used by listeners to enhance the reception of speech. By minimizing the disproportionate effects of background noise and reverberation on speech perception by people with hearing disabilities, auditory assistance devices improve the quality of the sound over that which would be received via a loudspeaker system.

2. The Commission takes this action in response to a petition for declaratory ruling filed by Williams Sound Corporation (Williams Sound Petition), a provider of wireless auditory assistance devices. Williams Sound asks the Commission to clarify that part 15 auditory assistance devices may be used to provide simultaneous language interpretation. This proposed amendment would expand the opportunities to deploy auditory assistance devices and remove barriers to communication, provide greater flexibility and enhanced benefits for persons wishing to use auditory assistance technologies, and harmonize the definition of “auditory assistance device” in part 15 of our rules with the definition of “auditory assistance communications” in part 95 of our rules. The Commission declines to grant the relief that Williams Sound has requested and instead is incorporating the issues raised in Williams Sound's petition into the NPRM.

Order

3. The Commission first addresses the Williams Sound petition for declaratory ruling. Williams Sound seeks a ruling that auditory assistance devices which operate under the part 15 rules in the 72-76 MHz bands may be used to provide simultaneous language interpretation and that such use is expressly included in the uses defined by 47 CFR 15.3(a). Under such an interpretation, the existing definition of an “auditory assistance device” would allow part 15 devices that operate in the 72-76 MHz bands to be used to provide simultaneous language interpretation for any individual that does not understand the language spoken in an audio presentation.

4. The Commission concludes that a declaratory ruling is not the appropriate vehicle to grant the relief requested by Williams Sound. Pursuant to § 1.2 of the Commission's rules, it may issue a declaratory ruling for purposes of “terminating a controversy or removing uncertainty.” However, a declaratory ruling may not be used to substantively change a rule. An analysis of the Commission's auditory assistance device rules in part 15 leads the Commission to the conclusion that by accepting Williams Sound's proposed interpretation, the Commission would expand the scope of permitted uses so significantly as to constitute a change in the rule. Section 15.3(a) of the Commission's rules states that an auditory assistance device is “[a]n intentional radiator used to provide auditory assistance to a handicapped person or persons. Such a device may be used for auricular training in an education institution, for auditory assistance at places of public gatherings, such as a church, theater, or auditorium, and for auditory assistance to handicapped individuals, only, in other locations.”

5. In 1982, the Commission addressed the issue of whether auditory assistance devices that operate in the 72-73 MHz and 75.4-76 MHz bands could be used for purposes other than serving handicapped individuals in response to petitions for rulemaking filed by Williams Sound and Phonic Ear, Inc. In that proceeding, the Commission expanded the use of auditory assistance devices that operate in the 72-73 MHz and 75.4-76 MHz bands beyond the initial limitations of operating solely in educational institutions and mere amplification of sounds to include any aural assistance that may be given to a handicapped person (e.g., audio description for the blind) but maintained the restrictions that these devices be used only by and for handicapped persons.

6. In 2009, the Commission issued a citation to ProLingo, a provider of simultaneous interpretation equipment and services, for marketing, as a component of its simultaneous language interpretation systems, transmitters operating on frequencies in the 72-76 MHz bands. ProLingo was found to have violated Section 302(b) of the Communications Act and §§ 2.803(a)(1) and 15.237 of the Commission's rules. Williams Sound appears to seek approval by declaratory ruling to conduct substantially the same activity that the Commission found to violate its rules. Furthermore, the Commission rejects Williams Sound's assertion that the inability to understand a foreign language can be considered a handicap, which thereby justifies permitting auditory assistance devices that operate in the 72-76 MHz bands to be used for simultaneous language interpretation. Such an interpretation is not consistent with the meaning given to the term “handicap” historically in part 1, subpart N of the Commission's rules, which was based on the Rehabilitation Act of 1973. The term was defined as a physical or mental impairment that substantially limits one or more of the major life activities of an individual. In 2003, the Commission replaced “handicap” with “disability” in part 1, subpart N, to be consistent with the Americans with Disabilities Act of 1990, but did not make any substantive changes to the definition. Williams Sound does not provide a basis for interpreting the term “handicap” in part 15 differently than the Commission has interpreted that term in part 1.

7. Together, these reasons lead the Commission to conclude that it would not be appropriate to grant the relief that Williams Sound has requested. The Commission believes, however, that Williams Sound provides good reasons for exploring whether expanding the part 15 definition of an “auditory assistance device” to permit such devices to be used for simultaneous language interpretation would benefit the public interest. Accordingly, on its own motion, the Commission addresses this matter in the NPRM.

Notice of Proposed Rulemaking

8. In this NPRM, the Commission proposes to amend the part 15 definition of an “auditory assistance device” to permit these devices to be used by anyone at any location for simultaneous language interpretation. As discussed by Williams Sound, the Commission believes that there are sound public policy reasons for allowing auditory assistance devices that operate in the 72-76 MHz bands to be used by persons who have language barriers but who may not be disabled. Expanding the scope of the rule would appear to be consistent with the Commission's goal of facilitating public access to telecommunications technologies. Many commenters, several of them providers of auditory assistance devices and/or simultaneous interpretation systems, support Williams Sound's Petition. Several of these commenters submit that allowing auditory assistance devices to be used in support of simultaneous language interpretation would also benefit individuals who have a hearing disability by promoting wider availability of auditory assistance devices in general. This, in turn, could facilitate communications with individuals that require both amplification and language interpretation. The Commission also finds merit in Williams Sound's observation that the use of auditory assistance devices that operate in the 72-76 MHz bands in support of simultaneous language interpretation would not only improve the aural experience and comprehension of those who need interpretation, but also would lower the noise level for those who do not care to listen to an interpreter, thereby enhancing the auditory experience of both groups.

9. Although current law requires operators of public gathering places to provide auditory assistance devices for use by persons with disabilities, operators of such venues may not decide who may benefit from these devices. However, the interference potential of an auditory assistance device is unrelated to the number of users or type of use. The Commission expects that expanding the permitted uses of part 15 auditory assistance devices that operate in the 72-76 MHz bands to include simultaneous language interpretation by anyone at any location will not increase their potential for harmful interference to authorized users in the 72-76 MHz or adjacent bands or impede the operation of other part 15 auditory assistance devices operating in the 72-76 MHz bands. In addition, because part 15 auditory assistance devices that operate in the 72-76 MHz bands use 200-kilohertz wide channels, ample spectrum is available for multiple applications. Thus, the Commission believes that part 15 auditory assistance devices that operate in the 72-76 MHz bands and provide simultaneous language interpretation should be able to simultaneously provide auditory assistance to persons with disabilities, and in any event, will not diminish the ability to provide auditory assistance to persons with disabilities.

10. For these reasons, the Commission proposes to amend the part 15 definition of “auditory assistance device” to permit these devices to be used by anyone at any location for simultaneous language interpretation as permitted under part 95, as reflected in the proposed rules set forth in Appendix A of the NPRM. The expanded definition would include any person requiring simultaneous language interpretation at any location. The Commission seeks comment on this proposal and its advantages and disadvantages. The Commission believes this action would serve the public interest by aiding the comprehension of individuals who require such interpretation. Moreover, expanding the permissible uses of part 15 auditory assistance devices to include simultaneous language interpretation would allow these devices to be used to provide either simultaneous language interpretation or auditory assistance, or both, thereby potentially providing a significant benefit to the public at no apparent additional cost. The Commission seeks comment on the potential benefits of expanding the allowable uses of part 15 auditory assistance devices to include simultaneous language interpretation. Do commenters agree with the Commission's assessment that its proposed rule change would not appear to impose additional costs? If not, the Commission seeks comment on any qualitative or quantitative costs associated with its proposal.

11. The Commission expects that expanding the types of operation permitted for part 15 auditory assistance devices to include simultaneous language interpretation for anyone at any location will result in an increase in their use. This could include operation of devices at locations where they are not also used to provide auditory assistance to disabled individuals. In addition, a greater number of channels may be operated at any given location where auditory assistance devices are used to provide both simultaneous language interpretation and auditory assistance for persons with disabilities. Thus, the Commission must also consider the effect that such increased use may have on other in-band, as well as adjacent-band, services.

12. The 72-73 MHz, 74.6-74.8 MHz, and 75.2-76 MHz bands, where part 15 auditory assistance device transmitters operate, are allocated on a primary basis to the fixed and mobile services. As indicated, these bands are available for licensed use under the Public Mobile Service (part 22), the Aviation Service (part 87), the Private Land Mobile Radio Service (part 90), and the Radio Control (R/C) Radio Service (part 95). In the bands adjacent to those where Part 15 auditory assistance devices operate, the 73-74.6 MHz band is allocated on a primary basis for radio astronomy, and the 74.8-75.2 MHz band is allocated on a primary basis to the aeronautical radionavigation service and is available for licensed use in the Radiodetermination Service (part 87). Additionally, the 66-72 MHz and 76-82 MHz bands (VHF TV channels 4 and 5, respectively) are allocated to the broadcast service and are available for licensed television broadcast stations (part 73).

13. With a maximum permissible ERP of 1.2 mW, the power of auditory assistance devices that operate in the 72-76 MHz bands is relatively low compared to that of authorized services in the 72-76 MHz and adjacent bands. Under the current rules which limit the location and types of use of part 15 auditory assistance devices, these devices have not been sources of interference to authorized services in these bands. The Commission seeks comment on whether increased use of part 15 auditory assistance devices for simultaneous language interpretation would increase the potential for harmful interference to authorized services in the 72-76 MHz and adjacent bands. If so, by how much, and what would the specific effects of such harmful interference be? If commenters believe there are qualitative or quantitative costs associated with increased use of part 15 auditory assistance devices for simultaneous language interpretation, the Commission asks that they discuss them. In particular, the Commission seeks comment on whether increased use of part 15 auditory assistance devices for simultaneous language interpretation would require additional safeguards or changes to the technical requirements to prevent harmful interference to authorized services in the 72-76 MHz (72-73 MHz, 74.6-74.8 MHz, and 75.2-76 MHz) and adjacent (66-72 MHz, 73-74.6 MHz, 74.8-75.2 MHz, and 76-82 MHz) bands, and if so, what rule changes are necessary. Are there any qualitative or quantitative costs associated with such rule changes? If so, the Commission asks commenters to discuss them.

14. Outside of the 72-76 MHz bands in which they operate, part 15 auditory assistance devices must comply with an emissions limit of 1,500 microvolts per meter (μV/m) measured at a distance of 3 meters. As noted above, the aeronautical radiodetermination, radio astronomy, and TV broadcast services are in bands adjacent to the part 15 auditory assistance device bands and are therefore potentially affected by out-of-band emissions from these auditory assistance devices. As with the case of in-band emissions from part 15 auditory assistance devices, the Commission is not aware of instances where auditory assistance devices have caused harmful interference to authorized services in adjacent bands. However, since the time the Commission adopted the rules for auditory assistance device transmitters in 1972, all full-service TV stations have converted from analog to digital transmissions. The Commission notes that in its proceeding proposing steps to open the TV spectrum to new wireless broadband services, it has sought comment on measures it could take to improve TV reception for consumers on VHF channels and encourage broadcasters to use these channels in the future. It noted that one of the problems with indoor VHF reception is noise from nearby consumer electronics equipment. The Commission stated that it would be desirable to reduce that noise, and while it declined to propose any specific changes, it sought comment on what actions it might take to reduce noise in the VHF TV bands.

15. The Commission notes that the allowed out-of-band emissions limit of 1,500 µV/m at 3 meters for auditory assistance devices that operate in the 72-76 MHz bands is 15 times higher (23.5 dB more power) than the § 15.209 emissions limit of 100 μV/m at 3 meters that applies to most other part 15 devices' emissions in the 72-76 MHz and adjacent bands. It is also 18 times higher (25 dB more power) than the out-of-band emissions limit that applies to part 15 personal/portable TV bands devices that operate in bands adjacent to occupied TV channels, which corresponds to 84 μV/m at 3 meters for a device operating at 40 mW. In light of the Commission's proposal to expand the permissible uses for part 15 auditory assistance devices to include simultaneous language interpretation and its goal of improving VHF TV reception, it seeks comment on whether there is a need to tighten the out-of-band emissions limits for part 15 auditory assistance devices. If so, what limit is appropriate—the § 15.209 limit, the unlicensed TV bands device limit, or some other limit? What are the potential advantages and disadvantages of each limit, and what specific qualitative or quantitative costs are associated with each limit? Are any other safeguards or technical requirements necessary to prevent harmful interference to authorized services in the adjacent 66-72 MHz, 73-74.6 MHz, 74.8-75.2 MHz, and 76-82 MHz bands? If so, what are the potential advantages and disadvantages and specific qualitative or quantitative costs associated with each? The Commission also notes that, based upon its review of the equipment authorization records for auditory assistance devices that operate in the 72-76 MHz bands, currently available equipment would not comply with the § 15.209 limits. If tighter limits are necessary, what would be the appropriate transition period for compliance with new limits? Should currently approved equipment be grandfathered, either for a limited time or permanently? If not, what specific qualitative or quantitative costs would be associated with acquiring equipment that complies with the § 15.209 limits?

16. The Commission recognizes that further restricting the out-of-band emissions of part 15 auditory assistance devices to protect the adjacent VHF TV bands would impose additional costs on manufacturers of these devices. Would the advantages of improving the reception of VHF TV channels 4 and 5 outweigh the disadvantages associated with further restricting part 15 auditory assistance device emissions to both manufacturers and users of these devices? The Commission requests specific information and data on the qualitative and quantitative costs associated with complying with additional safeguards or changes to the technical requirements and/or more restrictive out-of-band emissions limits. For example, the Commission requests information on technologies that could be used to decrease out-of-band emissions and the advantages and disadvantages of each; the cost to manufacturers and users to meet lower out-of-band emissions limits; and whether further reducing the out-of-band emissions would in any way impair the device's performance in other ways and how. The Commission also requests comment on any benefits for authorized services in the 72-76 MHz and adjacent bands by reducing the out-of-band emissions of these devices.

18. Pursuant to Sections 4(i), 303(f), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(f), and 303(r), the petition for declaratory ruling filed by Williams Sound Corporation filed on September 25, 2009, is denied.

19. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Notice of Proposed Rulemaking, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

Initial Regulatory Flexibility Analysis

20. As required by the Regulatory Flexibility Act of 1980, as amended (RFA),1 the Commission has prepared this present Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities by the policies and rules proposed in this NPRM. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines specified on the first page of this NPRM. The Commission will send a copy of this NPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA).2 In addition, the NPRM and IRFA (or summaries thereof) will be published in the Federal Register.3

1See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601-612, has been amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), Public Law 104-121, Title II, 110 Stat. 857 (1996).

2See 5 U.S.C. 603(a).

3See 5 U.S.C. 603(a).

A. Need for, and Objectives of, the Proposed Rule

21. This NPRM proposes to modify § 15.3(a) definition of “auditory assistance device” to allow part 15 unlicensed auditory assistance devices to be used by anyone at any location for simultaneous language interpretation. The proposal is designed to expand the permitted uses of part 15 auditory assistance devices to include a use other than those for the disabled (i.e., amplification of sound for those with a hearing disability and audio description for the blind) to facilitate public access to telecommunications technology. Permitting part 15 audio assistance devices that operate in the 72.0-73.0 MHz, 74.6-74.8 MHz, and 75.2-76.0 MHz bands (72-76 MHz bands) to be used by anyone at any location for simultaneous language interpretation would benefit persons requiring simultaneous language interpretation whether or not they have a disability. The NPRM seeks comment on whether allowing auditory assistance devices that operate in the 72-76 MHz bands to also be used by anyone at any location for simultaneous language interpretation will increase the potential for harmful interference to authorized services in the 72-76 MHz and adjacent bands (i.e., 66-72 MHz, 73-74.6 MHz, 74.8-75.2 MHz, and 76-82 MHz), and if so, whether additional safeguards or technical requirements are necessary to prevent harmful interference to these authorized services.

C. Description and Estimate of the Number of Small Entities to Which the Proposed Rule Will Apply

23. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted.4 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.5 A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.6

4Id. at 603(b)(3).

5 5 U.S.C. 601(3) (incorporating by reference the definition of “small business concern” in 15 U.S.C. 632). Pursuant to the RFA, the statutory definition of a small business applies “unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate to the activities of the agency and publishes such definition(s) in the Federal Register.” 5 U.S.C. 601(3).

6 Small Business Act, 15 U.S.C. 632 (1996).

24. Nationwide, there are a total of approximately 29.6 million small businesses, according to the SBA.7 A “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” 8 Nationwide, as of 2002, there were approximately 1.6 million small organizations.9 The term “small governmental jurisdiction” is defined generally as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” 10 Census Bureau data for 2002 indicate that there were 87,525 local governmental jurisdictions in the United States.11 The Commission estimates that, of this total, 84,377 entities were “small governmental jurisdictions.” 12 Thus, the Commission estimates that most governmental jurisdictions are small.

12 The Commission assumes that villages, school districts, and special districts are small, and they total 48,558. See U.S. Census Bureau, Statistical Abstract of the United States: 2006, section 8, page 273, Table 417. For 2002, Census Bureau data indicate that the total number of county, municipal, and township governments nationwide was 38,967, of which 35,819 were small. Id.

D. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements for Small Entities

25. This NPRM addresses the possibility of allowing additional flexibility for part 15 auditory assistance devices that operate in the 72-76 MHz bands by expanding the definition of allowed uses of part 15 auditory assistance devices to include simultaneous language interpretation for anyone at any location. This item does not contain any new reporting or recording keeping requirements.

E. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered

26. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.13

13 5 U.S.C. 603(c).

27. If the part 15 definition of auditory assistance device is expanded to include simultaneous language interpretation for anyone as an allowed use at any location, it may be necessary to modify the administrative and/or technical requirements for auditory assistance devices that operate in the 72-76 MHz bands to prevent harmful interference to authorized services in the 72-76 MHz and adjacent bands (i.e., 66-72 MHz, 73-74.6 MHz, 74.8-75.2 MHz, and 76-82 MHz).

28. Although the proposed rule is not expected to have a significant economic impact on small entities, the Commission will continue to examine alternatives with the objectives of eliminating unnecessary regulations and minimizing significant economic impact on small entities. The Commission seeks comment on significant alternatives that should be adopted.

F. Federal Rules That May Duplicate, Overlap, or Conflict With the Proposed Rule

29. None.

List of Subjects in 47 CFR Part 15

Communications equipment.

Federal Communications Commission.Marlene H. Dortch,Secretary.

For the reasons set forth in the preamble, the Federal Communications Commission proposes to amend part 15 of Title 47 of the Code of Federal Regulations to read as follows:

PART 15—RADIO FREQUENCY DEVICES

1. The authority citation for part 15 continues to read as follows:

Authority:

47 U.S.C. 154, 302a, 303, 304, 307, 336, and 544a.

2. Section 15.3 is amended by revising paragraph (a) to read as follows:

§ 15.3Definitions.

(a) Auditory assistance device. An intentional radiator used to provide auditory assistance communications (including but not limited to applications such as assistive listening, auricular training, audio description for the blind, and simultaneous language translation) for:

(1) Persons with disabilities. In the context of the part 15 rules, the term “disability,” with respect to the individual, has the meaning given to it by section 3(2)(A) of the Americans with Disabilities Act of 1990 (42 U.S.C. 12102(2)(A)), i.e., a physical or mental impairment that substantially limits one or more of the major life activities of such individuals;

(2) Persons who require language translation; or

(3) Persons who may otherwise benefit from auditory assistance communications in places of public gatherings, such as a church, theater, auditorium, or educational institution.

The Office of Federal Procurement Policy (OFPP), Cost Accounting Standards (CAS) Board, invites public comments concerning this proposed to clarify the application of the exemption from CAS at 48 CFR 9903.201-1(b)(15) for firm-fixed-price (FFP) contracts and subcontracts awarded on the basis of adequate price competition without submission of cost or pricing data (hereafter referred to as the “(b)(15) FFP exemption”). The proposed rule will revise the (b)(15) FFP exemption to clarify that the exemption applies to firm-fixed-price contracts and subcontracts awarded on the basis of adequate price competition without submission of certified cost or pricing data.

DATES:

Comment date: Comments must be in writing and must be received by December 5, 2011.

ADDRESSES:

All comments to this proposed rule must be in writing. Electronic comments may be submitted in any one of three ways:

1. Federal eRulemaking Portal: Comments may be directly sent via http://www.regulations.gov—a Federal E-Government Web site that allows the public to find, review, and submit comments on documents that agencies have published in the Federal Register and that are open for comment. Simply type “(b)(15) FFP exemption” (without quotation marks) in the Comment or Submission search box, click Go, and follow the instructions for submitting comments;

2. E-mail: Comments may be included in an e-mail message sent to casb2@omb.eop.gov. The comments may be submitted in the text of the e-mail message or as an attachment;

3. Facsimile: Comments may also be submitted via facsimile to (202) 395-5105; or

Be sure to include your name, title, organization, postal address, telephone number, and e-mail address in the text of your public comment and reference “(b)(15) FFP exemption” in the subject line irrespective of how you submit your comments. Comments received by the date specified above will be included as part of the official record. Comments delayed due to use of regular mail may not be considered.

Please note that all public comments received will be available in their entirety at http://www.whitehouse.gov/omb/casb_index_public_comments/ and http://www.regulations.gov after the close of the comment period. Do not include any information whose disclosure you would object to.

Rules, Regulations and Standards issued by the CAS Accounting Standards Board (Board) are codified at 48 CFR Chapter 99. This proposed rule concerns the amendment of a CAS Board regulation other than a Standard, and as such is not subject to the statutorily prescribed rulemaking process for the promulgation of a Standard at 41 U.S.C. 1502(c) [formerly, 41 U.S.C. 422(g)].

B. Background and Summary

Section 802 of the National Defense Authorization Act for Fiscal Year 2000 (Pub. L. 106-65) contained a provision for “Streamlined Applicability of Cost Accounting Standards.” Included in the provision was a revision to paragraph (2)(B) of Section 26(f) of the Office of Federal Procurement Policy Act (41 U.S.C. 1502(b)(1)(C) [formerly, 41 U.S.C. 422(f)(2)(B)]) that exempted from the application of CAS, “Firm-fixed-price contracts or subcontracts awarded on the basis of adequate price competition without submission of certified cost or pricing data.”

Section 802 adopted the recommendation of the Cost Accounting Standards Board Review Panel of the General Accounting Office (GAO) (as it was then called—the name was changed effective July 7, 2004 to the Government Accountability Office) that examined the future role of the CAS Board. In its report of April 2, 1999, the panel observed that a contracting officer is generally not allowed to request certified cost or pricing data where there is adequate price competition, the prices are set by law or regulation, or the acquisition is for commercial items. The panel noted that the risk to the Government in negotiating contract prices in these circumstances is not considered high enough to warrant obtaining certified cost or pricing data. The panel opined that the Government's risk assessment should be equally applicable to CAS and concluded that when certified cost or pricing data were not obtained for FFP contracts and subcontracts, the safeguards provided by CAS were likewise not necessary.

Section 802 was implemented by the CAS Board as an interim rule on February 7, 2000 (65 FR 5990), and as a final rule on June 9, 2000 (65 FR 36768). At the time, the CAS Board chose to express the (b)(15) FFP exemption as follows: “Firm-fixed-price contracts or subcontracts awarded on the basis of adequate price competition without submission of cost or pricing data.” The term “certified” was not used. The CAS Board explained that it chose this wording in order to conform to the statutory requirements of 10 U.S.C. 2306(h)(1) and 41 U.S.C. 3502(b) [formerly, 41 U.S.C. 254(b)] which defined “cost or pricing data” as data that requires certification. That is, the phrase “cost or pricing data” was understood to mean “certified cost or pricing data.”

On August 30, 2010, the Civilian Agency Acquisition Council and Defense Acquisition Regulations Council (Councils) issued a final rule to clarify the distinction between “certified cost or pricing data” and “data other than certified cost or pricing data,” as well as to clarify requirements for submission of cost or pricing data (75 FR 53135). Among other things, the Councils revised the definitions at Federal Acquisition Regulation (FAR) 2.101 related to cost or pricing data. Included within the definition of “data other than certified cost or pricing data” is a statement that such data may include the identical types of data as “certified cost or pricing data,” but without the certification. Thus, the definitions of both “certified cost or pricing data” and “data other than certified cost or pricing data” refer to cost or pricing data.

C. Conclusion

The CAS Board believes the August 30, 2010 revisions to FAR 2.101 may cause some confusion over the applicability of CAS in view of the current wording of the (b)(15) FFP exemption. Consistent with Section 802, it has not been the CAS Board's intent to apply CAS to FFP contracts or subcontracts awarded on the basis of adequate price competition where certified cost or pricing data was not obtained. Therefore, the CAS Board is considering a proposed change to the wording of the (b)(15) FFP exemption.

D. Paperwork Reduction Act

The Paperwork Reduction Act (44 U.S.C. Chapter 35, Subchapter I) does not apply to this rulemaking, because this rule imposes no additional paperwork burden on offerors, affected contractors and subcontractors, or members of the public which requires the approval of OMB under 44 U.S.C. 3501, et seq. The purpose of this proposed rule is to clarify the implementation of the “Streamlined Applicability of Cost Accounting Standards” at Section 802 of National Defense Authorization Act for Fiscal Year 2000.

E. Executive Order 12866, the Congressional Review Act, and the Regulatory Flexibility Act

This rule serves to clarify the elimination of certain administrative requirements associated with the application and administration of the Cost Accounting Standards by covered Government contractors and subcontractors, consistent with the provisions of “Streamlined Applicability of Cost Accounting Standards” at Section 802 of National Defense Authorization Act for Fiscal Year 2000. The economic impact on contractors and subcontractors is, therefore, expected to be minor. As a result, the CAS Board has determined that this proposed rule will not result in the promulgation of an “economically significant rule” under the provisions of Executive Order 12866, and that a regulatory impact analysis will not be required. Finally, this rule does not have a significant effect on a substantial number of small entities because small businesses are exempt from the application of the Cost Accounting Standards. Therefore, this proposed rule does not require a regulatory flexibility analysis under the Regulatory Flexibility Act of 1980, 5 U.S.C. Chapter 6.

List of Subjects in 48 CFR Part 9903

Cost accounting standards, Government procurement.

Daniel I. Gordon,Chair, Cost Accounting Standards Board.

For the reasons set forth in this preamble, chapter 99 of Title 48 of the Code of Federal Regulations is proposed to be amended as set forth below:

PART 9903—CONTRACT COVERAGE

1. The authority citation for Part 9903 continues to read as follows:

Authority:

Public Law 111-350, 124 Stat. 3677, 41 U.S.C. 1502.

SUBPART 9903.2—CAS PROGRAM REQUIREMENTS

2. Section 9903.201-1 is amended by revising paragraph (b)(15) to read as follows:

9903.201-1 CAS applicability.

(b) * * *

(15) Firm-fixed-price contracts or subcontracts awarded on the basis of adequate price competition without submission of certified cost or pricing data.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Advance notice of proposed rulemaking.

SUMMARY:

NMFS, in consultation with the Atlantic States Marine Fisheries Commission (Commission) and the New England and Mid-Atlantic Fishery Management Councils (Councils), is considering changes to the current system of regulations that limit the potential size of a replacement vessel. This advance notice of proposed rulemaking (ANPR) provides background information and requests public comment on the administrative and financial burdens of the current system, as well as on what type of changes would be appropriate to reduce that burden and the regulatory complexity without adversely affecting the fishery. NMFS will consider all recommendations received in response to this ANPR prior to any proposed rulemaking.

DATES:

Comments must be received on or before December 5, 2011.

ADDRESSES:

You may submit comments on this document, identified by NOAA-NMFS-2011-0213, by any of the following methods:

• Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal http://www.regulations.gov. To submit comments via the e-Rulemaking Portal, first click the “submit a comment” icon, and then enter NOAA-NMFS-2011-0213 in the keyword search. Locate the document you wish to comment on from the resulting list and click on the “Submit a Comment” icon on the right of that line.

Instructions: Comments must be submitted by one of the above methods to ensure that the comments are received, documented, and considered by NMFS. Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered. All comments received are a part of the public record and will generally be posted for public viewing on http://www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.) submitted voluntarily by the sender will be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word or Excel, WordPerfect, or Adobe PDF file formats only.

Measures to limit the potential size of a replacement vessel were first implemented in the Northeast Region in 1994 in conjunction with the adoption of limited access permits in the Northeast Multispecies and Atlantic Scallop Fishery Management Plans (FMP). NMFS enacted these measures to promote conservation of the fish species by limiting the potential increase in fishing capacity of the fleet and thereby maintaining total fishing mortality within the requirements of the respective rebuilding schedule of the FMP. In the following years, NMFS adopted limited access permits for other fisheries in the Northeast, some of which included various restrictions on how a permitted vessel could be replaced. In 1999, an omnibus amendment (Consistency Amendment) to all the FMPs of the Councils was implemented (64 FR 8263, February 19, 1999) to expand and standardize the upgrade restrictions to encompass most of the limited access fisheries in the Northeast.

The current regulations restrict the size and horsepower of any replacement vessel, or modifications to the current vessel, based on the specifications of a baseline vessel. The baseline vessel for each limited access permit is typically the first vessel issued the limited access permit in that fishery at the time that permit was issued. In the case of fisheries that adopted baseline restrictions through the Consistency Amendment, the permitted vessel as of the date of the final rule's implementation sets the baseline. In some cases, this methodology resulted in a single vessel with permits for multiple fisheries having more than one baseline. In that situation, the most restrictive combination of baseline specifications applies, unless the vessel owner chooses to relinquish permanently the permit with the more restrictive baseline(s).

Current regulations allow vessel owners to increase (or upgrade) a specification either by moving the limited access permit to a new vessel or by modifying the current vessel, up to 10 percent above of the baseline vessel's length overall, gross registered tonnage, and net tonnage and up to 20 percent above the baseline vessel's horsepower. As a matter of NMFS policy, all calculated maximum upgrade values are rounded up to the next whole number. The baseline size and horsepower specifications associated with a permit can only be upgraded once, although the vessel size characteristics (length overall, gross registered tonnage, and net tonnage) and engine horsepower can be upgraded at different times. For example, a vessel owner looking to replace his current vessel, which has a baseline engine horsepower of 300, may, if the horsepower on that permit was not upgraded before, move it to a vessel with up to 360 horsepower (20 percent greater than the 300-horsepower baseline). If the owner opts for a new vessel with a 340-horsepower engine, that action counts as the one-time upgrade, and any future replacement vessel could not exceed that new 340-horsepower maximum limit. The baseline size characteristics can be upgraded through this same vessel replacement or used another time. However, since size characteristics are upgraded as a group, if the baseline length overall is upgraded but not the gross and net tonnages, the baseline tonnage specifications cannot be upgraded in the future.

When a vessel owner wants to move a limited access Federal fishery permit to a replacement vessel, as part of the application he must provide documentation from a third party to demonstrate that the length, gross registered tonnage, net tonnage, and horsepower are within the limits for that permit. Many vessels use the U.S. Coast Guard vessel documentation certificate for length and tonnages, although the documentation certificate should then reflect the length overall as required by NMFS regulation, rather than the typical registered length. Vessels that are not documented by the U.S. Coast Guard must provide other documentation for vessel size. Obtaining vessel specification documents may involve the time and expense of having the new vessel measured by a marine surveyor or other qualified individual. Engine horsepower documentation may require testing by a marine mechanic and documentation of the results on formal letterhead. On the other hand, all of this information might be routinely obtained for other purposes (e.g., for insurance coverage) and it could be a minimal additional cost to provide copies as part of a permit transfer application. The cost of documenting vessel specifications has been previously estimated at $375 for calculating the burden to the public under the requirements of the Paperwork Reduction Act. The full cost to the industry of this process is not clear, and the public is encouraged to submit comments on how much of a financial and time burden this process has been.

Some members of the fishing industry have reported that it can be difficult to find a suitable replacement vessel within allowed upgrades, especially for small boats. For example, a replacement for a 25-ft (7.6-m) baseline vessel could not exceed 28 ft (8.5 m), and manufacturers may not make vessels in the allowed size range that also meet other specific needs of a vessel owner. Similarly, modern marine engines are manufactured to meet more stringent emissions standards, and horsepower ratings may not be as adjustable as in the past without violating those limits. The safety of a vessel at sea, especially in adverse weather conditions, is affected by many factors, including the size of the vessel. NMFS encourages comments from the public on the availability of suitable replacement vessels, and the impact this has on safety at sea.

The primary justification for the adoption of upgrade restrictions was to control the potential increase in catch from each permitted vessel that could occur with increases in vessel size and horsepower and, therefore, to prevent unexpected increases in fishing mortality that could hinder a rebuilding program. Since the initial implementation of vessel upgrade and replacement restrictions, many fisheries have also adopted trip limits or other measures that control the potential harvest of a vessel beyond just restricting vessel size. In addition, the recent adoption in all fisheries of annual catch limits that cap total harvest in a given year may reduce the concern over excessive fishing mortality. In light of these other measures, it is possible that vessel baseline restrictions could be relaxed without adversely affecting stock rebuilding. However, the upgrade restriction is considered one factor that is helping to preserve the small vessel character of the fishing fleet in the Northeast region. Larger and more powerful vessels could also have increased impacts on habitat or bycatch of non-target species. Further, fishery management actions adopted by the coastal states through the Commission may rely on the baseline upgrade restrictions for federally permitted vessels to control harvest potential. These considerations will have to be more fully understood before a change to current regulation can be implemented.

A wide range of options could be considered as part of any action to change vessel baseline regulations. NMFS would like public input on the full range of potential actions, including suggestions for other changes to baseline regulations that are not specifically listed in this announcement, such as how to treat vessels that have multiple baselines and/or have already upgraded under the current system. Potential changes may include one or more of the following.

1. Eliminate tonnages from vessel baseline regulations. The tonnages are often considered the most malleable of baseline specifications. The gross registered tonnage can vary significantly depending on whether exact measurements or the simplified calculation method is used. Similarly, net tonnage can be calculated based either on the gross tonnage or from measurements of the vessel, and may be changed by modifying internal bulkheads. Tonnage has also been a concern for owners of vessels built outside of the United States that are determined to be under 5 net tons (14.16 m3) for import purposes.

2. Eliminate the one-time upgrade provision. This would eliminate the incentive to use as much of the available upgrade as possible to avoid “losing” some amount of future upgrade. The change could also simplify upgrade considerations by establishing the maximum specifications of any future vessel without needing to know whether any specification has already been upgraded. For example, under this option, if the permit on your vessel has a baseline horsepower specification of 300, and at some point moved to a vessel with 340 horsepower, a future replacement vessel could still be up to 360 horsepower (20 percent greater than the 300-horsepower baseline).

3. Change from a system of fixed upgrades to a system of size classes. This option would allow a vessel owner to move a permit to any vessel that fits within the specified size class. The specifics of this type of change, including the number and size of the size classes, have not been fully developed, and NMFS seeks comment to this end. Specific size classes could be based on vessel length, horsepower, or a combination. Such a system would simplify the vessel replacement considerations by making them uniform for all vessels in a particular size class rather than the current system where potential upgrades are unique to each permit. However, determining specific size classes that are appropriate for all fisheries may be difficult, and such a system might disadvantage vessels that are already at the upper limit of a size class.

4. Remove baseline upgrade restrictions for vessels under 30 ft (9.1 m). The Councils discussed this potential measure in 1998 during the development of the Consistency Amendment, and again in 2003, but took no formal action at either time. This approach would remove the burden on the smallest vessels as long as they stay under 30 ft (9.1 m), but would establish upgrade provisions that are not uniform for all vessels, which might be confusing or seen as unfair.

5. Complete removal of upgrade restrictions. This would allow any vessel owner to move his/her permit to any other vessel. It would provides maximum flexibility to the industry, but would remove the baseline system's restrictions on fleet structure and would likely have the largest impacts on the fishery and the environment.

The long comment period for this ANPR is intended to overlap with meetings of both Councils. While this topic may be discussed at the Council meetings, please submit written comments on the burden of the current vessel baseline system, the potential changes outlined here, or any suggestions for other changes that might be appropriate through one of the methods identified in the ADDRESSES section of this ANPR, to ensure that they are fully considered.

In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to send comments regarding any aspect of this proposed information collection. This is a new collection for the National Food Study.

DATES:

Written comments on this notice must be received on or before December 5, 2011 to be assured of consideration.

ADDRESSES:

Address all comments concerning this notice to Mark Denbaly, Food Economics Division, Economic Research Service, U.S. Department of Agriculture, 355 E St., SW., Room 05N09, Washington, DC 20024-3221. Comments may also be submitted via fax to the attention of Mark Denbaly at 202-245-4779 or via e-mail to mdenbaly@ers.usda.gov. Comments will also be accepted through the Federal eRulemaking Portal. Go to http://www.regulations.gov, and follow the online instructions for submitting comments electronically.

All written comments will be open for public inspection at the office of the Economic Research Service during regular business hours (8:30 a.m. to 5 p.m., Monday through Friday) at 355 E St., SW., Washington, DC 20024-3221.

All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

FOR FURTHER INFORMATION CONTACT:

For further information contact Mark Denbaly at the address in the preamble. Tel. 202-694-5390.

SUPPLEMENTARY INFORMATION:

Title: National Food Study.

OMB Number: 0536-XXXX.

Expiration Date: Three years from the Date of Approval.

Type of Request: New Collection.

Abstract: The National Household Food Acquisition and Purchase Study (the National Food Study) will be conducted over a six-month period from April through September 2012. The survey will collect nationally representative data from 5,000 households, including 1,500 households participating in the Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp Program). Each participating household will be asked to provide the pertinent information over a one-week period. Legislative authority for the planned data collection is Section 17 (a)(1) of the Food and Nutrition Act of 2008, 7 U.S.C. 2026. This section authorizes the Secretary to enter into contracts with private institutions to undertake research that will help improve the administration and effectiveness of the SNAP in delivering nutrition-related benefits.

The information to be collected by the National Food Study is necessary to assess and understand the relationships among: (1) Foods purchased for consumption at home and away from home over a one-week period, as well as foods acquired through food and nutrition assistance programs (both public and private); (2) household access to food, including locations where food is acquired and distance to acquisition points; (3) number of meals and snacks consumed by each household member during a one-week period; and (4) household characteristics, including income, participation in federal food assistance programs, non-food expenditures, food security, health status, and diet and nutrition knowledge of the primary food shopper.

This survey will provide data not currently available to program officials and researchers, thereby broadening the scope of economic analyses of food choices made by U.S. households and how those choices influence diet quality and reflect decisions about participation in food assistance programs. The information to be collected by the survey is necessary to assess and understand the relationships among: (1) The types of foods and beverages households purchase, including those obtained and consumed away from home; (2) the nutritional quality of these foods and beverages; (3) the types of food retailers within proximity to households; (4) the influence of household income and food prices on purchases of food brought home and food consumed away from home; (5) levels of food security and the relationships between food security and types of food purchases; (6) levels of dietary knowledge and the relationship with types of food purchases; and (7) differences in food acquisition and food security outcomes between SNAP participants and nonparticipants.

This nationally representative survey will collect data from a planned 5,000 households selected at random from within 50 Primary Sampling Units (counties or groups of counties) in 27 States. The sample will be selected from an address-based sampling frame. Households residing at selected addresses will be asked to complete a brief screener to determine eligibility. Eligible households will be asked to participate in the one-week survey. The primary respondent, identified as the primary food shopper, will be asked to use a handheld scanner provided by the study to scan barcodes on all foods brought into the home for a one-week period. All members of the household age 11 years and older will be asked to keep a food diary of all foods that they acquire and consume away from home during the one-week period; primary respondents will report the food diary information for all household members via brief telephone interviews three times during the week. The primary household respondent will also be asked to complete two interviews: (1) Household Interview #1 will be conducted in person by a field interviewer at the start of the data collection week and will collect information about household demographics, food shopping, and participation in food assistance programs; (2) Household Interview #2 will be conducted in person at the end of the data collection week and will collect information about non-food expenditures, income, health status, diet and nutrition knowledge, and food security. The primary household respondent will be asked to complete two paper forms: (1) the Meals and Snacks form contains a grid with checkboxes to indicate the meals and snacks consumed by each household member on each day of the one-week data collection period; (2) the Respondent Feedback form contains four questions about household participation in the survey, to be completed at the end of the data collection week. To conduct the economic analyses of household food choice behavior, data from state agencies about participation in food programs may be used in combination with collected data. Any state data obtained will be kept strictly confidential. The confidential program data and linked files will be used solely for statistical and economic research purposes that inform program administration, not for enforcement purposes.

All study instruments will be kept as simple and respondent-friendly as possible. Responses are voluntary and confidential. Study instruments and procedures were tested during the National Food Study Field Test, conducted from February through May 2011. The field test collected data from 400 households selected at random from within two Primary Sampling Units (counties), and tested the efficacy of two alternate survey protocols for collecting food data and two different incentive levels for time spent completing the forms.

Responses from the National Food Study will be combined for statistical purposes and reported only in aggregate or statistical form. Two sets of data files will be prepared from survey data: (1) Public use data files that will not contain any personal identifiers like names and addresses of respondents; and (2) restricted-access files that will contain all data items in the public use files, plus geocodes for households and public locations (stores and restaurants) where foods were acquired.

Estimated Number of Respondents: The estimated number of respondents includes: (1) 24,675 households screened for income eligibility (it is expected that 19,740 households, or 80 percent, will complete the screener and 4,935, or 20 percent, will not); (2) of the 7,726 households expected to be determined to be eligible for the survey after completing the screener, 5,795 (75 percent) are expected to agree to participate and complete Household Interview #1 and collect food data, and 1,932, (25 percent) will not; (3) of the 5,795 households who complete Household Interview #1 5,099 (88 percent) are expected to complete reporting of food obtained for home preparation and consumption, three Telephone interviews to report food away from home, and Household Interview #2, while 695 (12 percent) will not; (4) of the 5,795 households who complete Household Interview #1, 4,925 (85 percent) are expected to complete the Meals and Snacks form and Respondent Feedback form, and 869 (15 percent) will not; and (5) of the expected 13,892 food diaries to be completed (i.e., an average of 2.4 family members per household), 12,225 diaries (88 percent) are expected to be completed and 1,667 (12 percent) will not.

Estimates of the percentages of respondents who will agree to complete the forms are based on the National Food Study Field Test (conducted from February through May 2011) and, insofar as possible, on experience with previous data collections of similar complexity.

Estimated Number of Responses per Respondent: 6.51 (average). Estimated responses per respondent are as follows: all 24,675 sampled households will be asked to respond to the screener once; an estimated 7,726 survey-eligible households will be asked to respond to Household Interview #1 once; and an estimated 5,795 households completing Household Interview #1 will be asked to respond to Household Interview #2 once.

The estimated 5,795 households completing Household Interview #1 will be asked to complete reports on and scan food brought into the home, with an estimated frequency of three times during the seven-day data collection period. An estimated 13,892 family members aged 11 and above (an average of 2.4 members per household) will be asked to complete seven daily food diaries for food not brought home. An estimated 5,795 households will be asked to report food diary information over the telephone three times, complete the Meals and Snacks form on each of 7 days, and complete the Respondent Feedback form once.

Estimated Total Annual Responses: 160,755.

Estimated Time per Response: 0.23 hours. As shown in the table below, the estimated time of response varies from 0.02 hours (1 minute) to 0.58 hours (35 minutes) per instrument for respondents and from 0.02 hours (1 minute) to 0.08 hours (5 minutes) per instrument for non-respondents. These estimates of respondent burden are based on the National Food Study field test.

Estimated Total Annual Burden on Respondents: 37,562.55 hours. See the table below for the estimated total annual burden for each type of instrument.

The Eastern Washington Cascades Provincial Advisory Committee and the Yakima Provincial Advisory Committee will meet on October 19, 2011, from 9 a.m. to 3 p.m. at the Okanogan-Wenatchee National Forest Headquarters Office, 215 Melody Lane, Wenatchee, WA and also on November 9, 2011, from 9 a.m. to 3 p.m. at Washington State Park office, 270 9th Street, NE., East Wenatchee, WA. During these meetings information will be shared about Access Travel Management. All Eastern Washington Cascades and Yakima Province Advisory Committee meetings are open to the public.

The Collaborative Forest Landscape Restoration Program (CFLRP) Advisory Committee will meet in person. The purpose of the meeting is to evaluate proposals submitted in response to the Fiscal Year 2011 CFLRP Request for Proposals and make recommendations for project selection to the Secretary of Agriculture.

DATES:

The meeting will be held October 18-20, 2011, from 8 a.m. to 5 p.m. M.DT.

ADDRESSES:

The meeting will be held at the Peery Hotel, located at 110 West Broadway, Salt Lake City, UT 84101. Written comments should be sent to Lauren Marshall, USDA Forest Service, Forest Management, Mailstop-1103, 1400 Independence Avenue, SW., Washington, DC 20250-1103. Comments may also be sent via e-mail to Lauren Marshall, lemarshall@fs.fed.us, or via facsimile to 202-205-1045.

All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at USDA Forest Service, Forest Management, 201 14th Street, SW., Yates Building, Washington, DC. Visitors are encouraged to call ahead to 202-205-1218 to facilitate entry into the Forest Service building.

Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Standard Time, Monday through Friday.

SUPPLEMENTARY INFORMATION:

The meeting is open to the public. Committee discussion is limited to Forest Service staff and Committee members. However, persons who wish to bring Collaborative Forest Landscape Restoration Program matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. Time for public input will be provided, during which individuals will have the opportunity to address the Committee.

The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

Agency: Bureau of Industry and Security (BIS).

Title: Additional Protocol Report Forms.

OMB Control Number: 0694-0135.

Form Number(s): AP-1 through AP-17, AP-A through AP-Q.

Type of Request: Regular submission (extension/revision of a currently approved information collection).

Burden Hours: 844.

Number of Respondents: 500.

Average Hours per Response: 22 to 360 minutes.

Needs and Uses: The Additional Protocol requires the United States to submit declaration forms to the International Atomic Energy Agency (IAEA) on a number of commercial nuclear and nuclear-related items, materials, and activities that may be used for peaceful nuclear purposes, but also would be necessary elements for a nuclear weapons program. These forms provides the IAEA with information about additional aspects of the U.S. commercial nuclear fuel cycle, including: Mining and milling of nuclear materials; buildings on sites of facilities selected by the IAEA from the U.S. Eligible Facilities List; nuclear-related equipment manufacturing, assembly, or construction; import and export of nuclear and nuclear-related items and materials; and research and development. The Protocol also expands IAEA access to locations where these activities occur in order to verify the forms' data. The revision involves text clarifications.

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to Jasmeet Seehra, OMB Desk Officer, e-mail to Jasmeet_K._Seehra@omb.eop.gov, or fax to (202) 395-5167.

An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Northwest Tennessee Regional Port Authority to establish a general-purpose foreign-trade zone at sites in Dyer, Gibson, Haywood, Lake, Lauderdale, Madison, Obion and Tipton Counties, Tennessee, adjacent to the Memphis Customs and Border Protection (CBP) port of entry, under the alternative site framework (ASF) adopted by the Board (74 FR 1170-1173, 1/12/09 (correction 74 FR 3987, 1/22/09); 75 FR 71069-71070, 11/22/10). The ASF is an option for grantees for the establishment or reorganization of general-purpose zones and can permit significantly greater flexibility in the designation of new “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the Board's standard 2,000-acre activation limit for a general-purpose zone project. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally filed on September 29, 2011. The applicant is authorized to make the proposal under Tennessee Code Sections 7-85-101 thru 7-85-103.

The proposed zone would be the third general-purpose zone in Tennessee for the Memphis CBP port of entry and would be the fifth zone overall for the port of entry. The existing zones are as follows: FTZ 77, Memphis, Tennessee (Grantee: City of Memphis, Board Order 189, April 2, 1982); FTZ 223, Memphis, Tennessee (Grantee: Memphis International Trade Development Corporation, Board Order 904, July 2, 1997); FTZ 262, Southaven, Mississippi (Grantee: Northern Mississippi FTZ, Inc., Board Order 1353, October 1, 2004); and, FTZ 273, West Memphis, Arkansas (Grantee: City of West Memphis, Arkansas, Board Order 1551, April 15, 2008).

The applicant's proposed service area under the ASF would be Dyer, Gibson, Haywood, Lake, Lauderdale, Madison, Obion and Tipton Counties, Tennessee. If approved, the applicant would be able to serve sites throughout the service area based on companies' needs for FTZ designation. The proposed service area is adjacent to the Memphis CBP port of entry.

The proposed zone would initially include nine “magnet” sites in the service area: Proposed Site 1 (350 acres)—Cates Landing, One Cates Landing, State Highway 22 and Donaldson Road, Tiptonville (Lake County); Proposed Site 2 (279 acres)—Dyersburg Industrial Park, located at the intersection of Interstate 155 and U.S. Highway 412, Dyersburg (Dyer County); Proposed Site 3 (197 acres)—Gibson County Industrial Park, 2725 N. Central Avenue, Humboldt (Gibson County); Proposed Site 4 (474 acres)—Brownsville South Industrial Park, located at the intersection of Highway 70/79 and Windrow Road, Brownsville (Haywood County); Proposed Site 5 (1,720 acres)—Mega Site, located along Interstate 40 near Highways 70 and 79, Stanton (Haywood County); Proposed Site 6 (161 acres)—Walker Industrial Park, 374 Highland Street, Ripley (Lauderdale County); Proposed Site 7 (55 acres)—American Drive Business Center, 96 American Drive, Jackson (Madison County); Proposed Site 8 (235 acres)—Obion County Industrial Park, located at the intersection of Highway 21 and U.S. Highway 51, Union City (Obion County); and, Proposed Site 9 (415 acres)—Rialto Industrial Park, Highway 51 North, Covington (Tipton County). The ASF allows for the possible exemption of one magnet site from the “sunset” time limits that generally apply to sites under the ASF, and the applicant proposes that Site 1 be so exempted.

The application indicates a need for zone services in the West Tennessee area. Several firms have indicated an interest in using zone procedures for warehousing/distribution activities for a variety of products. Specific manufacturing approvals are not being sought at this time. Such requests would be made to the Board on a case-by-case basis.

In accordance with the Board's regulations, Camille Evans of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the Board.

Public comment is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is December 5, 2011. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to December 19, 2011.

A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue, NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via http://www.trade.gov/ftz. For further information, contact Camille Evans at Camille.Evans@trade.gov or (202) 482-2350.

On April 1, 2011, the Department of Commerce (the Department) published a notice of initiation of the administrative reviews of the antidumping duty orders on certain frozen warmwater shrimp From India and Thailand covering the period February 1, 2010, through January 31, 2011. See Certain Frozen Warmwater Shrimp From Brazil, India, and Thailand: Notice of Initiation of Administrative Reviews, 76 FR 18157 (Apr. 1, 2011).

Extension of Time Limit of Preliminary Results

Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), requires the Department to make a preliminary determination in an administrative review within 245 days after the last day of the anniversary month of an order or finding for which a review is requested. Consistent with section 751(a)(3)(A) of the Act, the Department may extend the 245-day period to 365 days if it is not practicable to complete the review within a 245-day period. The deadline for the preliminary results of these administrative reviews is currently October 31, 2011. The Department determines that completion of the preliminary results of these reviews within the statutory time period is not practicable because it recently initiated a cost investigation for one respondent in each review and the data necessary to conduct these investigations will not be received until late September (for Thailand) and early October 2011 (for India). The Department thus requires additional time to conduct its cost analysis in each of these reviews. Therefore, in accordance with section 751(a)(3)(A) of the Act, we are extending the time period for issuing the preliminary results of these reviews until February 28, 2012. The final results continue to be due 120 days after the publication of the preliminary results.

This notice is published pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2).

Pursuant to Section 6(c) of the Educational, Scientific and Cultural Materials Importation Act of 1966 (Pub. L. 89-651, as amended by Pub. L. 106-36; 80 Stat. 897; 15 CFR part 301), we invite comments on the question of whether instruments of equivalent scientific value, for the purposes for which the instruments shown below are intended to be used, are being manufactured in the United States.

Comments must comply with 15 CFR 301.5(a)(3) and (4) of the regulations and be postmarked on or before October 25, 2011. Address written comments to Statutory Import Programs Staff, Room 3720, U.S. Department of Commerce, Washington, DC 20230. Applications may be examined between 8:30 a.m. and 5 p.m. at the U.S. Department of Commerce in Room 3720.

Docket Number: 11-059. Applicant: University of Arkansas Office of Business Affairs, ADMN 321, 1 University of Arkansas, Favetteville, AR 72701-1201. Instrument: Electron Microscope. Manufacturer: JEOL, Ltd., Japan. Intended Use: The instrument will be used to study semiconductor materials, metals, ceramics, and biological tissues, to determine the influence of impurities on medicine efficiency, the kinetics of the growth of particles in a specific environment, the phase transformation of metals, and the study of other phenomena. Justification for Duty-Free Entry: There are no instruments of the same general category manufactured in the United States. Application accepted by Commissioner of Customs: September 15, 2011.

Docket Number: 11-062. Applicant: University of Buffalo, NYS Center for Excellence, 701 Ellicott St., HJKRI B4-321, Buffalo, NY 14203. Instrument: Electron Microscope. Manufacturer: FEI, Czech Republic. Intended Use: The instrument will be used to study the normal and pathological brains and peripheral nerves from animal models, assessing the degree and quality of myelination and neuronal differentiation under different experimental conditions. The objective of the experiments is to discover treatments and cures for Krabbe and other demyelinating disease. The experiments require 2-angstrom resolution in order to examine the specimens. Justification for Duty-Free Entry: There are no instruments of the same general category manufactured in the United States. Application accepted by Commissioner of Customs: September 7, 2011.

Docket Number: 11-063. Applicant: Mount Sinai School of Medicine, 1 Gustave L. Levy Place New York, NY 10029-6574. Instrument: Electron Microscope. Manufacturer: JEOL Ltd., Japan. Intended Use: The instrument will be used to image a wide range of biological assemblies composed of protein, nucleic acids, lipid and detergent. The studies will include structural studies of nucleic acid binding protein, viruses and membrane proteins, among other research. A 120kV electron microscope with an anticontaminator and specimen holder suitable for imaging biological samples at liquid nitrogen temperatures is required for the research. Justification for Duty-Free Entry: There are no instruments of the same general category manufactured in the United States. Application accepted by Commissioner of Customs: September 16 2011.

Docket Number: 11-064. Applicant: University of Wyoming, 1000 E University Ave., Laramie, WY 82071. Instrument: Electron Microscope. Manufacturer: FEI, Czech Republic. Intended Use: The instrument will be used to study solar energy and materials science research. There are no other instruments with the necessary resolution that are also capable of operation at very high pressures (chamber pressures approaching atmospheric pressures), which are essential for the research applications. There are also no microscopes manufactured in the United States that are capable of spatial resolution on the nanometer scale, and generation and analysis of electron-beam induced signals such as characteristic x-ray analysis, electron beam induced current measurements, and e-beam lithography. Justification for Duty-Free Entry: There are no instruments of the same general category manufactured in the United States. Application accepted by Commissioner of Customs: September 16, 2011.

Background: The CINTAC was established under the discretionary authority of the Secretary of Commerce and in accordance with the Federal Advisory Committee Act (5 U.S.C. App.), in response to an identified need for consensus advice from U.S. industry to the U.S. Government regarding the development and administration of programs to expand United States exports of civil nuclear goods and services in accordance with applicable United States laws and regulations, including advice on how U.S. civil nuclear goods and services export policies, programs, and activities will affect the U.S. civil nuclear industry's competitiveness and ability to participate in the international market.

Topics to be considered: The agenda for the November 4, 2011 CINTAC meeting is as follows:

Closed Session (9 a.m.-3 p.m.)

1. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. App. (10)(a)(1) and 10(a)(3).

The open session will be disabled-accessible. Public seating is limited and available on a first-come, first-served basis. Members of the public wishing to attend the meeting must notify Mrs. Sarah Lopp at the contact information below by 5 p.m. EDT on Friday, October 28, 2011 in order to pre-register for clearance into the building. Please specify any requests for reasonable accommodation at least five business days in advance of the meeting. Last minute requests will be accepted, but may be impossible to fill.

A limited amount of time will be available for pertinent brief oral comments from members of the public attending the meeting. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of 30 minutes. Individuals wishing to reserve speaking time during the meeting must contact Mrs. Lopp and submit a brief statement of the general nature of the comments and the name and address of the proposed participant by 5 p.m. EDT on Friday, October 28, 2011. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the International Trade Administration (ITA) may conduct a lottery to determine the speakers. Speakers are requested to bring at least 20 copies of their oral comments for distribution to the participants and public at the meeting.

Any member of the public may submit pertinent written comments concerning the CINTAC's affairs at any time before and after the meeting. Comments may be submitted to the Civil Nuclear Trade Advisory Committee, Office of Energy & Environmental Industries, Room 4053, 1401 Constitution Ave., N.W., Washington, DC 20230. For consideration during the meeting, and to ensure transmission to the Committee prior to the meeting, comments must be received no later than 5 p.m. EDT on Friday, October 28, 2011. Comments received after that date will be distributed to the members but may not be considered at the meeting.

The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on April 20, 2011, pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App. (10)(d)), that the portion of the meeting dealing with matters the disclosure of which would be likely to frustrate significantly implementation of an agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. App. (10)(a)(1) and 10(a)(3). The portion of the meeting dealing with matters requiring disclosure of trade secrets and commercial or financial information as described in 5 U.S.C. 552b(c)(4) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. App. §§ (10)(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.

Copies of CINTAC meeting minutes will be available within 90 days of the meeting.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Notice of availability.

SUMMARY:

NMFS has received an application for an incidental take permit (Permit) from the North Carolina Division of Marine Fisheries (NCDMF) pursuant to the Endangered Species Act of 1973, as amended (ESA). As required by the ESA, NCDMF's application includes a conservation plan designed to minimize and mitigate take of endangered or threatened species. The permit application is for the incidental take of ESA-listed adult and juvenile sea turtles associated with otherwise lawful commercial gill net fisheries operating in inshore waters of North Carolina. The duration of the proposed permit is for 3 years. NMFS is providing this notice to allow other agencies and the public an opportunity to review and comment on the application and associated conservation plan. All comments received will become part of the public record and will be available for review.

DATES:

Written comments from interested parties on the permit application and Plan must be received at the appropriate address or fax number (see ADDRESSES) no later than 5 p.m. Eastern daylight time on December 5, 2011.

ADDRESSES:

You may submit comments on the permit application and conservation plan, identified by NOAA-NMFS-2011-0231, by any of the following methods during the 60-day comment period:

• Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal http://www.regulations.gov. To submit comments via the e-Rulemaking Portal, first click the “submit a comment” icon, then enter NOAA-NMFS-2011-0231 in the keyword search. Locate the document you wish to comment on from the resulting list and click on the “Submit a Comment” icon on the right of that line.

Instructions: Comments must be submitted by one of the above methods to ensure that the comments are received, documented, and considered by NMFS. Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered. All comments received are a part of the public record and will generally be posted for public viewing on http://www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.) submitted voluntarily by the sender will be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word or Excel, WordPerfect, or Adobe PDF file formats only.

Section 9 of the ESA and Federal regulations prohibit the “taking” of a species listed as endangered or threatened. The term “take” is defined under the ESA to mean harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. NMFS may issue permits, under limited circumstances, to take listed species incidental to, and not the purpose of, otherwise lawful activities. Section 10(a)(1)(B) of the ESA provides for authorizing incidental take of listed species. NMFS regulations governing permits for threatened and endangered species are published at 50 CFR 222.307.

NMFS issued Permit No. 1259 to NCDMF (65 FR 65840, November 2, 2000), Permit No. 1348 (66 FR 51023, October 5, 2001), Permit No. 1398 (67 FR 67150, November 4, 2002), and Permit No. 1528 (70 FR 52984, September 6, 2005) authorizing the incidental take of the foregoing species in certain segments of the commercial fall gill net fisheries for flounder in Pamlico Sound subject to a series of mandatory sea turtle management and monitoring requirements and limits on the numbers of individuals that could be taken annually. On August 18, 2011, NCDMF submitted a revised application to NMFS for Permit No. 16230, authorizing incidental take of ESA-listed sea turtles associated with commercial and recreational gillnet fisheries in inshore state waters for 3 years. This application includes endangered Kemp's ridley, leatherback, and hawksbill sea turtles and threatened green and loggerhead sea turtles. This permit, if issued, and implementing the conservation plan would allow for the incidental take of specified numbers of sea turtles incidental to the continued commercial harvest of target fish species subject to conservation, management and monitoring requirements set forth in the plan and as permit conditions deemed necessary and appropriate by the NMFS.

Conservation Plan

The conservation plan prepared by NCDMF describes measures designed to monitor, minimize, and mitigate the incidental take of ESA-listed sea turtles. The conservation plan includes managing inshore gill net fisheries by dividing estuarine waters into 5 management units (i.e., A-E). Each of the management units would be monitored seasonally and by fishery.

Management Units were delineated on the basis of three primary factors: Similarity of fisheries and management; extent of known protected species interactions in commercial gill net fisheries; and unit size and the ability of the NCDMF to monitor fishing effort. Management Unit A encompasses all estuarine waters north of 35° 46.30′ N to the North Carolina/Virginia state line. This includes all of Albemarle, Currituck, Croatan, and Roanoke sounds as well as the contributing river systems in this area. Management Unit B encompasses all estuarine waters South of 35° 46.30′ N, East of 76° 28.00′ W and North of 34° 48.27′ N. This Management Unit will include all of Pamlico Sound and the Northern portion of Core Sound. Management Unit C will include the Pamlico, Pungo and Neuse river drainages west of 76° 28.00′ W. Management Unit D is divided into two areas, D-1 and D-2, to allow the NCDMF to effectively address areas of high sea turtle abundance or “hot spots.” Management Unit D-1 encompasses all estuarine waters South of 34° 48.27′ N. and east of a line running from 34° 40.70′ N.-76° 22.50′ W. to 34° 42.48′ N.-76° 36.70′ W. Management Unit D-1 includes Southern Core Sound, Back Sound and North River. Management Unit D-2 encompasses all estuarine waters west of a line running from 34° 40.70′ N.-76° 22.50′ W. to 34° 42.48′ N.-76° 36.70′ W. to the Western side of White Oak River. Management Unit D-2 includes Newport River, Bogue Sound and White Oak River. Management Unit E encompasses all estuarine waters south and west of the Western side of the White Oak River to the North Carolina/South Carolina state line. This includes the Atlantic Intercoastal Waterway and adjacent sounds, and the New, Cape Fear, Lockwood Folly and Shallotte rivers.

The large mesh (≥ 5 inch stretched mesh (12.7 cm)) gill net fisheries primarily target southern flounder (Paralicthys lethostigma), striped bass (Morone saxatilis), American shad (Alosa americana), hickory shad (Polomolobus mediocris), and catfishes (Ictalurus sp.). Large mesh gill net fisheries for flounder traditionally operate throughout the majority of the sounds and lower estuarine river systems with peaks in effort in the spring/summer months (April-June), and in the fall months (September-November). Fisheries for striped bass are more limited in time and space due to the anadromous migration pattern of this species. Striped bass gill net fisheries are prosecuted from late October through late April; fishermen are prohibited from targeting striped bass from May through early October. Consequently, the majority of striped bass effort occurs in Albemarle Sound with seasonal effort occurring in the Pamlico Sound and the Pamlico and Neuse River systems. American and hickory shad fishing operations occur almost exclusively from January 1 through April 14 due to their anadromous migration patterns and distribution. Catfish are harvested with large mesh gill nets in the river and Western Albemarle Sound with the majority of catches occurring during the winter to spring months. The most common mesh size for all large mesh gill net fisheries is 51/2 inch (13.97 cm) stretched mesh.

The small mesh (<5 inch stretched mesh (12.7 cm)) gillnet fisheries primarily target spot (Leiostomus xanthurus), striped mullet (Mugil cephalus), bluefish (Pomatomus saltatrix), spotted seatrout (Cynoscion nebulosus), weakfish (Cynoscion regalis), Atlantic menhaden (Brevoortia tyrannus), Spanish mackerel (Scomberomorus maculates), white perch (Morone americana), and kingfishes (Menticirrhus sp.). Peaks in spot landings occur in the spring/summer (April to June) and fall (October to November) months; spot are landed throughout the estuarine waters and river systems. Striped mullet are landed year round with peaks in the fall/winter months (October to January). Bluefish are also landed year round throughout the estuarine and river systems with most landings occurring in the spring during April and May. Spotted seatrout and weakfish are targeted by small mesh gillnet operations primarily in the fall/winter (September to January) months. Weakfish landings may also peak in the spring during April and May. Atlantic menhaden are mostly targeted during the spring (February to May) with another peak in landings occurring in October. Spanish mackerel are primarily targeted during the spring and fall months. White perch are almost exclusively targeted during the winter/spring months (December to April). Kingfishes are targeted primarily in the spring and the fall throughout the estuarine and river systems. Mesh sizes used in small mesh gill net operations vary more than those used in large mesh fisheries. However, the most commonly used small mesh sizes generally fall between 3 inch (7.62 cm) and 33/4 inch (9.53 cm) stretched mesh.

Management measures identified in the Conservation Plan include: (1) Restricted soak times for large mesh gillnets from one hour before sunset on Monday through Thursday and one hour after sunrise from Tuesday through Friday (i.e., fishing is prohibited from one hour after sunrise on Friday through one hour before sunset on Monday); (2) restrictions on the maximum net length per large mesh fishing operation (i.e., 2,000 yards (1.83 km, 6,000 ft) per operation except south of the NC Highway 58 bridge where 1,000 yards (0.91 km, 3,000 ft) is maximum; (3) restrictions on large mesh net-shot lengths to 100 yards (91.44 m, 300 ft) with a 25 yard (22.86 m, 75 ft) separation between each net-shot; and (4) requirement for large mesh nets to be low profile (e.g., maximum of 15 meshes in depth, tie-downs prohibited, floats or corks prohibited along float lines north of the NC Highway 58 bridge). NCDMF proposes to monitor sea turtle interactions through reports from fishery observers (both traditional and alternative platform), fishermen, and NCDMF Marine Patrol at a minimum of 7% coverage annually for large mesh gillnet trips. The proposed conservation plan also includes a requirement for NCDMF to provide monthly reports of sea turtle interactions to NMFS with estimates of take by management unit, season, sea turtle species, and disposition.

The annual incidental take of sea turtles, using a 90% confidence limit, is anticipated to be 295 lethal and 607 non-lethal. Specifically, the anticipated lethal and non-lethal take by species is 55 lethal and 116 non-lethal Kemp's ridley, 216 lethal and 436 non-lethal green, 23 lethal and 50 non-lethal loggerhead turtles, and 1 lethal and 5 non-lethal hawksbill turtles. NCDMF is proposing to limit inshore gillnet fisheries such that the impacts on ESA-listed sea turtles will be minimized. NCDMF would use a variety of adaptive fishery management measures and restrictions through their state proclamation authority to reduce sea turtle mortality and prohibit fishing in Management Units or sub-units where incidental take thresholds are exceeded. NCDMF considered and rejected one other alternative, not applying for a permit and closing the fishery, when developing their conservation plan.

National Environmental Policy Act

Issuing a permit would constitute a Federal action requiring NMFS to comply with the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq.) as implemented by 40 CFR parts 1500-1508 and NOAA Administrative Order 216-6, Environmental Review Procedures for Implementing the National Environmental Policy Act (1999). NMFS intends to prepare an Environmental Assessment (EA) to consider a range of reasonable alternatives and fully evaluate the direct, indirect, and cumulative impacts likely to result from issuing a permit.

Next Steps

This notice is provided pursuant to section 10(c) of the ESA. NMFS will evaluate the application, associated documents, and comments submitted thereon to determine whether the application meets the requirements of section 10(a) of the ESA. If we determine that the requirements of section 10(a) and the procedural requirements of NEPA are met, NMFS will issue a permit for incidental takes of ESA-listed sea turtles under the jurisdiction of NMFS. The final NEPA and permit determinations will not be completed until after the end of the 60-day comment period. NMFS will fully consider all public comments received during the comment period. NMFS will publish a record of its final action in the Federal Register.

National Telecommunications and Information Administration, U.S. Department of Commerce.

ACTION:

Notice of open meeting.

SUMMARY:

This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee). The Committee provides advice to the Assistant Secretary of Commerce for Communications and Information on spectrum management policy matters.

DATES:

The meeting will be held on November 10, 2011, from 9 a.m. to 12 p.m., Eastern Standard Time.

ADDRESSES:

The meeting will be held at the U.S. Department of Commerce, 1401 Constitution Avenue, NW., Room 4830, Washington, DC 20230. Public comments may be mailed to Commerce Spectrum Management Advisory Committee, National Telecommunications and Information Administration, 1401 Constitution Avenue, NW., Room 4099, Washington, DC 20230 or e-mailed to spectrumadvisory@ntia.doc.gov.

Background: The Committee provides advice to the Assistant Secretary of Commerce for Communications and Information on needed reforms to domestic spectrum policies and management in order to: license radio frequencies in a way that maximizes their public benefits; keep wireless networks as open to innovation as possible; and make wireless services available to all Americans (See charter, at http://www.ntia.doc.gov//page/2011/csmac-charter). This Committee is subject to the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, and is consistent with the National Telecommunications and Information Administration Act, 47 U.S.C. § 904(b). The Committee functions solely as an advisory body in compliance with the FACA. For more information about the Committee visit: http://www.ntia.doc.gov/category/CSMAC.

Matters To Be Considered: The Committee will deliberate on the findings and recommendations from its four subcommittees (Search for 500 MHz, Spectrum Sharing, Spectrum Management Improvements, and Unlicensed), and identify future requirements for assessments. NTIA will post a detailed agenda on its Web site, http://www.ntia.doc.gov, prior to the meeting. There also will be an opportunity for public comment at the meeting.

Time and Date: The meeting will be held on November 10, 2011, from 9 a.m. to 12 p.m., Eastern Standard Time. The times and the agenda topics are subject to change. The meeting may be webcast or made available via audio link. Please refer to NTIA's Web site, http://www.ntia.doc.gov, for the most up-to-date meeting agenda and access information.

Place: The meeting will be held at the U.S. Department of Commerce, National Telecommunications and Information Administration, 1401 Constitution Avenue, NW., Room 4830, Washington, DC 20230. The meeting will be open to the public and press on a first-come, first-served basis. Space is limited. The public meeting is physically accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Mr. Washington, at (202) 482-6415 or BWashington@ntia.doc.gov, at least five (5) business days before the meeting.

Status: Interested parties are invited to attend and to submit written comments to the Committee at any time before or after the meeting. Parties wishing to submit written comments for consideration by the Committee in advance of this meeting must send them to NTIA's Washington, DC office at the above-listed address and comments must be received by close of business on October 28, 2011, to provide sufficient time for review. Comments received after October 28, 2011, will be distributed to the Committee, but may not be reviewed prior to the meeting. It would be helpful if paper submissions also include a compact disc (CD) in HTML, ASCII, Word, or WordPerfect format (please specify version). CDs should be labeled with the name and organizational affiliation of the filer, and the name of the word processing program used to create the document. Alternatively, comments may be submitted electronically to spectrumadvisory@ntia.doc.gov. Comments provided via electronic mail also may be submitted in one or more of the formats specified above.

Records: NTIA maintains records of all Committee proceedings. Committee records are available for public inspection at NTIA's Washington, DC office at the address above. Documents including the Committee's charter, member list, agendas, minutes, and any reports are available on NTIA's Committee web page at http://www.ntia.doc.gov/category/CSMAC.

The Coordinating Council on Juvenile Justice and Delinquency Prevention (Council) announces its October 2011 meeting.

DATES:

Friday, October 21 from 10 a.m. to 12:30 p.m.

ADDRESSES:

The meeting will take place in the third floor main conference room at the U.S. Department of Justice, Office of Justice Programs, 810 7th St., NW., Washington, DC 20531.

FOR FURTHER INFORMATION:

Visit the Web site for the Coordinating Council at http://www.juvenilecouncil.gov or contact Robin Delany-Shabazz, Designated Federal Official, by telephone at 202-307-9963 [Note: this is not a toll-free telephone number], or by e-mail at Robin.Delany-Shabazz@usdoj.gov. The meeting is open to the public.

SUPPLEMENTARY INFORMATION:

The Coordinating Council on Juvenile Justice and Delinquency Prevention, established pursuant to Section 3(2)A of the Federal Advisory Committee Act (5 U.S.C. App. 2) will meet to carry out its advisory functions under Section 206 of the Juvenile Justice and Delinquency Prevention Act of 2002, 42 U.S.C. 5601, et seq. Documents such as meeting announcements, agendas, minutes, and reports will be available on the Council's Web page, http://www.juvenilecouncil.gov, where you may also obtain information on the meeting.

Although designated agency representatives may attend, the Council membership is composed of the Attorney General (Chair), the Administrator of the Office of Juvenile Justice and Delinquency Prevention (Vice Chair), the Secretary of Health and Human Services (HHS), the Secretary of Labor, the Secretary of Education, the Secretary of Housing and Urban Development, the Director of the Office of National Drug Control Policy, the Chief Executive Officer of the Corporation for National and Community Service, and the Assistant Secretary of Homeland Security for U.S. Immigration and Customs Enforcement. The nine additional members are appointed by the Speaker of the House of Representatives, the Senate Majority Leader, and the President of the United States. Other federal agencies take part in Council activities including the Departments of Agriculture, Defense, the Interior, and the Substance and Mental Health Services Administration of HHS.

Meeting Agenda

The preliminary agenda for this meeting includes: (a) A presentation on Strengthening Military Families organized by the Office of Children and Youth, U. S. Department of Defense; (b) an update on interagency efforts to promote adoption of effective approaches to school discipline; (c) a demonstration by the U.S. Department of Housing and Urban Development and GreatSchools of their initiative to provide evidence-based data to help inform families' decisions about housing and schools; and (d) other agency announcements.

Registration

For security purposes, members of the public who wish to attend the meeting must pre-register online at http://www.juvenilecouncil.gov no later than Friday, October 14, 2011. Should problems arise with web registration, call Daryel Dunston at 240-221-4343 or send a request to register to Mr. Dunston. Include name, title, organization or other affiliation, full address and phone, fax and e-mail information and send to his attention either by fax to 301-945-4295, or by e-mail to ddunston@edjassociates.com. [Note: these are not toll-free telephone numbers.] Additional identification documents may be required. Space is limited.

Note:

Photo identification will be required for admission to the meeting.

Written Comments: Interested parties may submit written comments and questions by Friday, October 14, 2011, to Robin Delany-Shabazz, Designated Federal Official for the Coordinating Council on Juvenile Justice and Delinquency Prevention, at Robin.Delany-Shabazz@usdoj.gov. The Coordinating Council on Juvenile Justice and Delinquency Prevention expects that the public statements presented will not repeat previously submitted statements. Written questions from the public may also be invited at the meeting.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

FOR FURTHER INFORMATION CONTACT:

Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.

The following is a copy of a letter to the Speaker of the House of Representatives, Transmittals 11-30 with attached transmittal and policy justification.

(iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase: Refurbishment of two SH-2G Helicopters being provided as grant Excess Defense Articles (EDA) to be modified for operational use. The two EDA aircraft will also be modified to include the following: HELRAS Helicopter Dipping SONAR, AAQ-22 Forward Looking Infrared Radar (FLIR), AN/APS-143C (V) 3 RADAR, ARC-210 UHF Radio, APX-72 Transponder, AN/ARN-147 VOR/ILS, AN/ARN-149 Receiver (ADF), HF-9000 HF Radio, ASN-150 Tactical Navigation Set, spare and repair parts, support and test equipment, publications and technical documentation, personnel training and training equipment, U.S. Government and contractor engineering, technical and logistics support services, and other related elements of logistical and program support.

(vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: None.

(viii) Date Report Delivered to Congress: 27 September 2011.

Policy JustificationEcuador—SH-2G Helicopters

The Government of Ecuador has requested a possible sale for the refurbishment of two SH-2G Helicopters being provided as grant Excess Defense Articles (EDA) to be modified for operational use. The two EDA aircraft will also be modified to include the following: HELRAS Helicopter Dipping SONAR, AAQ-22 Forward Looking Infrared Radar (FLIR), AN/APS-143C (V) 3 RADAR, ARC-210 UHF Radio, APX-72 Transponder, AN/ARN-147 VOR/ILS, AN/ARN-149 Receiver (ADF), HF-9000 HF Radio, ASN-150 Tactical Navigation Set, spare and repair parts, support and test equipment, publications and technical documentation, personnel training and training equipment, U.S. Government and contractor engineering, technical and logistics support services, and other related elements of logistical and program support. The estimated cost is $60 million.

This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of Ecuador which has been, and continues to be, an important force for political stability and economic progress in South America. This proposed sale will also improve the interoperability between the naval forces of the United States and Ecuador.

The proposed sale will improve Ecuador's capability to meet current and future anti-ship threats. The helicopters will perform antisubmarine warfare (ASW), antisurface warfare, search and rescue (SAR), and logistics support missions for the Ecuadorian Navy. They will improve Ecuador's ability to participate in the Maritime Multinational Operations with the U.S. Navy, will enhance Ecuador's control of its territorial sea and exclusive economic zone, and will increase the Ecuadorian Navy's SAR capabilities, further reducing Ecuador's dependency on the United States in case of emergencies. Additionally, these specialized ASW Helicopters would constitute a highly effective system to search, track, and destroy the mini-submarines used for illegal drug trafficking. Similar items have not previously been provided to Ecuador.

The proposed sale of this equipment and support will not alter the basic military balance in the region.

The prime contractor will be Kaman Corporation of Bloomfield, CT. There are no known offset agreements proposed in connection with this potential sale.

Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to Ecuador.

There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

The Office of the Secretary of Defense notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on September 29, 2011, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

Students receiving non-DoD schooling funded by DoDEA and their sponsors and tutors.

Categories of Records In The System:

Student Record Files. Demographic data includes student name, date of birth, grade, school attended, school year, special education services including tutorial and supplemental services, if applicable tuition paid by DoDEA, and applicable transportation payments.

This information is used to track obligations and invoices for transportation, tuition, and tutoring payments and to determine eligibility and enrollment by grade for all students who receive non-DoD schooling funded by DoD. This information is also used as a management tool for statistical analysis, tracking, reporting, evaluating program effectiveness and conducting research.

Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of Such Uses:

In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, these records may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

To a non-DoD school, upon request of the school, when the child is enrolled in the school or receiving services from the school at DoD expense, so long as the disclosure is for purposes related to the student's enrollment or receipt of services.

To state and local social service offices in response to law enforcement inquiries and investigations, and child placement/support proceedings.

The DoD ‘Blanket Routine Uses’ set forth at the beginning of the Office of the Secretary of Defense (OSD) compilation of systems of records notices also apply to this system.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:

Storage:

Paper file folders and electronic storage media.

Retrievability:

Records may be retrieved by name, address, school year. Student records are also retrieved by grade, sponsor's name, or school name.

Safeguards:

Access is provided on a “need-to-know” basis and to authorized authenticated personnel only. The Non-DoD School Program system database requires the user to utilize a two-factor authentication and a system password. Paper records are maintained in controlled access areas. Program access, assignment and monitoring are the responsibility of DoDEA headquarters functional managers.

Retention and Disposal:

Documents and electronic records on enrollment and registration, school registration forms, parental correspondence, other notes and related information and similar records are destroyed five (5) years after transfer, withdrawal, or death of student.

Tutor record files are destroyed six (6) years and three (3) months after period covered by account.

Records of students not approved for the program are destroyed one year after end of school year.

Individuals seeking to determine whether information about themselves is contained in this system of records should address written inquiries to the Privacy Act Officer, Department of Defense Education Activity, 4040 North Fairfax Drive, Arlington, VA 22203-1365.

Requests should contain the individual's name, address, and school year. Requests for student records should also include student's full name under which enrolled at time of attendance, sponsor's SSN (for verification), name of school, and year of graduation or last date of attendance, daytime telephone number, and address record should be mailed.

Record Access Procedures:

Individuals seeking access to records about themselves contained in this system of records should address written inquiries to the Privacy Act Officer, Department of Defense Education Activity, 4040 North Fairfax Drive, Arlington, VA 22203-1364.

Requests should contain the individual's name, address, and school year. Requests for student records should also include student's full name under which enrolled at time of attendance, sponsor's SSN (for verification), name of school, and year of graduation or last date of attendance, daytime telephone number, and address record should be mailed. The request should also contain the name and number of this system of records and be signed.

Contesting Record Procedures:

The OSD rules for accessing records, for contesting contents and appealing initial agency determinations are published in OSD Administrative Instruction 81; 32 CFR part 311; or may be obtained from the systems manager.

Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

The National Security Agency/Central Security System systems of records notices subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT.

The specific changes to the records system being amended are set forth below followed by the notice, as amended, published in its entirety. The proposed amendment is not within the purview of subsection (r) of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, which requires the submission of a new or altered system report.

Changes:Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

In any legal proceeding, where pertinent, to which DoD is a party before a court or administrative body (including, but not limited to the Equal Employment Opportunity Commission and Merit Systems Protection Board).

To any entity or individual under contract with NSA/CSS for the purpose of providing Employee Assistance Service related services.

Note:

Record of the identity, diagnosis, prognosis, or treatment of any client/patient, irrespective of whether or when he ceases to be a client/patient, maintained in connection with the performance of any alcohol or drug abuse prevention and treatment function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States, shall, except as provided therein, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized in 42 U.S.C. 290dd-2. This statute takes precedence over the Privacy Act of 1974, in regard to accessibility of such records except to the individual to whom the record pertains. The DoD `Blanket Routine Uses' that appear at the beginning of the NSA/CSS compilation of systems of records notices do not apply to these types of records.

Note:

This system of records contains individually identifiable health information. The DoD Health Information Privacy Regulation (DoD 6025.18-R) issued pursuant to the Health Insurance Portability and Accountability Act of 1996, applies to most such health information. DoD 6025.18-R may place additional procedural requirements on the uses and disclosures of such information beyond those found in the Privacy Act of 1974 or mentioned in this system of records notice.

Safeguards:

Delete entry and replace with “Employee Assistance Service facilities are limited-access facilities for security-cleared personnel and visitors only. Facilities may also be patrolled or secured by guarded pedestrian gates and checkpoints. Inside of Employee Assistance Service office spaces, paper/hard-copy records are stored in locked containers with limited access. Access to electronic records is limited and controlled by password.”

Retention and disposal:

Delete entry and replace with “Records of clients are retained locally (at Employee Assistance Service facilities/offices) and transferred to the NSA/CSS Records Center three years after case closure. Then, after five years, records are destroyed by pulping, burning, shredding, erasure or destruction of magnetic media.

Records of clients who retire or separate are retained locally (at Employee Assistance Service facilities/offices) and transferred to the NSA/CSS Records Center one year after date of separation or retirement. Then, after five years, records are destroyed by pulping, burning, shredding, erasure or destruction of magnetic media.”

Notification Procedure:

Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, MD 20755-6248.

Written inquiries should contain the individual's full name, SSN, mailing address, and signature.”

Record Access Procedures:

Delete entry and replace with “Individuals seeking access to information about themselves contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, MD 20755-6248.

Written inquiries should contain the individual's full name, SSN, mailing address, and signature.”

Contesting Record Procedures:

Delete entry and replace with “The NSA/CSS rules for contesting contents and appealing initial determinations are published at 32 CFR Part 322 or may be obtained by written request addressed to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, MD 20755-6248.”

Used by counselors to facilitate and record treatment, referral and follow-up on behalf of employees.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

In any legal proceeding, where pertinent, to which DoD is a party before a court or administrative body (including, but not limited to the Equal Employment Opportunity Commission and Merit Systems Protection Board).

To any entity or individual under contract with NSA/CSS for the purpose of providing Employee Assistance Service related services.

Note:

Record of the identity, diagnosis, prognosis, or treatment of any client/patient, irrespective of whether or when he ceases to be a client/patient, maintained in connection with the performance of any alcohol or drug abuse prevention and treatment function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States, shall, except as provided therein, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized in 42 U.S.C. 290dd-2. This statute takes precedence over the Privacy Act of 1974, in regard to accessibility of such records except to the individual to whom the record pertains. The DoD `Blanket Routine Uses' that appear at the beginning of the NSA/CSS compilation of systems of records notices do not apply to these types of records.

Note:

This system of records contains individually identifiable health information. The DoD Health Information Privacy Regulation (DoD 6025.18-R) issued pursuant to the Health Insurance Portability and Accountability Act of 1996, applies to most such health information. DoD 6025.18-R may place additional procedural requirements on the uses and disclosures of such information beyond those found in the Privacy Act of 1974 or mentioned in this system of records notice.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:

Storage:

Paper in file folders and electronic storage media.

Retrievability:

By the individual's name and/or SSN.

Safeguards:

Employee Assistance Service facilities are limited-access facilities for security-cleared personnel and visitors only. Facilities may also be patrolled or secured by guarded pedestrian gates and checkpoints. Inside of Employee Assistance Service office spaces, paper/hard-copy records are stored in locked containers with limited access. Access to electronic records is limited and controlled by password.

Retention and disposal:

Records of clients are retained locally (at Employee Assistance Service facilities/offices) and transferred to the NSA/CSS Records Center three years after case closure. Then, after five years, records are destroyed by pulping, burning, shredding, erasure or destruction of magnetic media.

Records of clients who retire or separate are retained locally (at Employee Assistance Service facilities/offices) and transferred to the NSA/CSS Records Center one year after date of separation or retirement. Then, after five years, records are destroyed by pulping, burning, shredding, erasure or destruction of magnetic media.

Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, MD 20755-6248.

Written inquiries should contain the individual's full name, SSN, mailing address, and signature.

Record Access Procedures:

Individuals seeking access to information about themselves contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, MD 20755-6248.

Written inquiries should contain the individual's full name, SSN, mailing address, and signature.

Contesting Record Procedures:

The NSA/CSS rules for contesting contents and appealing initial determinations are published at 32 CFR part 322 or may be obtained by written request addressed to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, MD 20755-6248.

Record source categories:

Primary sources are Employee Assistance Service counselors, the client and the client's family. Other sources include other counselors and other individuals within NSA/CSS.

Exemptions claimed for the system:

Portions of this system may be exempt under 5 U.S.C. 552a(k)(1), (k)(2), (k)(4) and (k)(5), as applicable.

Information specifically authorized to be classified under E.O. 13526, as implemented by DoD 5200.1-R, may be exempt pursuant to 5 U.S.C. 552a(k)(1).

Investigatory material compiled for law enforcement purposes, other than material within the scope of subsection 5 U.S.C. 552a(j)(2), may be exempt pursuant to 5 U.S.C. 552a(k)(2). However, if any individual is denied any right, privilege, or benefit for which he would otherwise be entitled by Federal law or for which he would otherwise be eligible, as a result of the maintenance of the information, the individual will be provided access to the information exempt to the extent that disclosure would reveal the identity of a confidential source. Note: When claimed, this exemption allows limited protection of investigative reports maintained in a system of records used in personnel or administrative actions.

Records maintained solely for statistical research or program evaluation purposes and which are not used to make decisions on the rights, benefits, or entitlements of any individual except for census records which may be disclosed under 13 U.S.C. 8, may be exempt pursuant to 5 U.S.C. 552a(k)(4).

Investigatory material compiled solely for the purpose of determining suitability, eligibility, or qualifications for federal civilian employment, military service, federal contracts, or access to classified information may be exempt pursuant to 5 U.S.C. 552a(k)(5), but only to the extent that such material would reveal the identity of a confidential source.

An exemption rule for this records system has been promulgated according to the requirements of 5 U.S.C. 553(b)(1), (2), and (3), (c) and (e) and published in 32 CFR part 322. For additional information, contact the system manager.

Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

The National Security Agency/Central Security System systems of records notices subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT.

The specific changes to the records system being amended are set forth below followed by the notice, as amended, published in its entirety. The proposed amendment is not within the purview of subsection (r) of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, which requires the submission of a new or altered system report.

Delete entry and replace with “Records are maintained for five years after the grant is completed and/or payment obligation as annotated in the student agreement is completed. Records are destroyed after five years by pulping, burning, shredding, or erasure or destruction of magnetic media.

Educational information to include: Official transcripts from all schools attended; Scholastic Assessment Test (SAT) and Graduate Record Examination (GRE) test scores; list of previous schools attended and degree/certification; self-certification of enrollment status at a Center for Academic Excellence (CAE) to included anticipated date of graduation, proposed university(ies) and proposed degree to include start date, student status and anticipated date of graduation.

Work related information to include: Current supervisor's name, office title, office address, office phone number, office fax number, office e-mail address; office of primary responsibility, name, position title, office address, e-mail, and phone number; application for the position the individual will fill on completion of the program and the desired DoD Agency; and Continued Service Agreement.

To maintain records relating to the processing and awarding of recruitment scholarships, retention scholarships or grants under the DoD Information Assurance Scholarship Program (IASP) to qualified applicants and institutions. This system is also used by management for tracking and reporting.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows: To authorized DoD hiring officials to facilitate the recruiting of DoD IASP award recipients into federal service for the purpose of fulfilling the DoD IASP mission.

Disclosure to consumer reporting agencies:

Disclosures pursuant to 5 U.S.C. 552a(b)(12), Records maintained on individuals, may be made from this system to consumer reporting agencies as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) or the Federal Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)). The purpose of this disclosure is to aid in the collection of outstanding debts owed to the Federal government, typically to provide an incentive for debtors to repay delinquent Federal government debts by making these debts part of their credit records.

The disclosure is limited to information necessary to establish the identity of the individual, including name, address, and taxpayer identification number (Social Security Number (SSN)); the amount, status, and history of the claim; and the agency or program under which the claim arose for the sole purpose of allowing the consumer reporting agency to prepare a commercial credit report.

The DoD “Blanket Routine Uses” set forth at the beginning of the NSA/CSS compilation of systems of records notices apply to this system.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:Storage:

Paper records in file folders and electronic storage media.

Retrievability:

Retrieved by the individual's name, SSN, institution's name and/or year of application.

Safeguards:

Buildings are secured by a series of guarded pedestrian gates and checkpoints. Access to facilities is limited to security-cleared personnel and escorted visitors only. Within the facilities themselves, access to paper and computer printouts is controlled by limited-access facilities and lockable containers. Access to electronic means is limited and controlled by computer password protection.

Retention and disposal:

Records are maintained for five years after the grant is completed and/or payment obligation as annotated in the student agreement is completed. Records are destroyed after five years by pulping, burning, shredding, or erasure or destruction of magnetic media.

Individuals seeking to determine whether records about themselves is contained in this record system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, Maryland 20755-6248.

Written requests should contain the individual's name, address, scholarship award year and type, and the institution attended. All requests must be signed.

Record Access procedures:

Individuals seeking access to information about themselves contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, Maryland 20755-6248.

Requests should include individual's name, address, scholarship award year and type, and the institution(s) attended. All requests must be signed.

Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

The Department of the Army notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on September 29, 2011 to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

Department of the Army, Navy, Marine Corps, Air Force, Reserve Officer Training Corps, National Defense Cadet Corps military personnel, Department of Defense civilian personnel, and approved foreign military personnel enrolled in a resident or non-resident course administered by the Army and enrolled to attend Army training.

Categories of Records in the System:

Course and personnel data to include: Individual's name, Social Security Number (SSN), foreign identification number, and date of birth.

Standardized Student Records System purpose is to obtain training, education, experiential learning, personal, and biographical data to present a comprehensive and personalized view of the student record, course enrollment, course completion, official grade transcript, statistical studies to improve training and testing methods, and course catalog information. Records are created to assist leadership to instill an ongoing attitude of comprehensive, continuous, and consistent military health surveillance to implement early intervention and control strategies to promote and safeguard the moral, the physical well-being, and the general welfare of personnel at TRADOC organizations.

Routine uses of records maintained in the system, including categories of users and the purpose of such uses:

In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

The DoD ‘Blanket Routine Uses' set forth at the beginning of the Army's compilation of system of record notices apply to this record system.

Note:

This system of records contains individually identifiable health information. The DoD Health Information Privacy Regulation (DoD 6025.18-R) issued pursuant to the Health Insurance Portability and Accountability Act of 1996, applies to most such health information. DoD 6025.18-R may place additional procedural requirements on the uses and disclosures of such information beyond those found in the Privacy Act of 1974 or mentioned in this system of records notice.

Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System:Storage:

Paper records and electronic storage media.

Retrievability:

By name, Social Security Number (SSN), foreign identification number, service number, class number, language, year of graduation, and date of birth.

Safeguards:

These systems are hosted on Army installations, in a secure environment. Building security is through police patrols, installation fences, key card access, building-server room alarms and cameras. System access is through the Army Network Enterprise Center's firewall. Each user requires a user ID and password (which has to be changed each 90 days). Direct access to the database is restricted to authorized System Administrators (SAs) only. Servers are located in a cipher locked room and access is controlled by the SA. Any person having access to personally identifiable information (PII) is specific only to them once they have been authenticated in the pertinent system through an incorporated security process, such as the implementation of User ID/Password—Common Access Cards (CAC); CAC optional but being mandated for CAC only access with the safeguards listed above. All personnel with access to PII are trained in Security+ certifications, to ensure they are current on new security standards.

Retention and Disposal:

Records are kept in current file area until no longer needed for conducting business, then retired to Records Holding Area (RHA)/Army Electronic Archive (AEA) or destroyed.

Individual academic records are transferred to the RHA/AEA, and are retired to National Records Personnel Center (NRPC) Annex, 1411 Boulder Drive, Rock City Industrial Center, Valmeyer, IL 62295-2603, when the record is 10 years old. The NPRC will destroy the record when 40 years old.

Instructor records are transferred to the RHA/AEA after transfer or separation of instructor, and are destroyed 10 years after the event.

Office personnel records are kept until transfer or separation of individual. Keep in CFA until event occurs and then until no longer needed for conducting business, but not longer than 6 years after the event, then destroy or transfer to the gaining activity; whether it is an on or off post transfer.

Records on local training and individual goals are maintained until no longer needed for conducting business, but not longer than 6 years, then destroyed.

Individual must furnish his/her full name, Social Security Number (SSN), current address and telephone number, and military status or other information verifiable from the record itself which may assist in locating the record, and their signature.

In addition, the requester must provide a notarized statement or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:If Executed Outside the United States:

`I declare (or certify, verify, or state) under penalty of perjury under the laws of the United State of America that the foregoing is true and correct. Executed on (date). (Signature)'.

If executed within the United States, its territories, possessions, or commonwealths:

`I declare (or certify, verify, or state) under penalty of perjury that the foregoing is true and correct. Executed on (date). (Signature)'.

Record Access Procedures:

Individuals seeking access to information about themselves contained in this system should address written inquiries to:

For verification purposes, individual must furnish his/her full name, Social Security Number (SSN), current address and telephone number, and military status or other information verifiable from the record itself which may assist in locating the record, and their signature.

In addition, the requester must provide a notarized statement or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:If Executed Outside the United States:

`I declare (or certify, verify, or state) under penalty of perjury under the laws of the United State of America that the foregoing is true and correct. Executed on (date). (Signature)'.

If executed within the United States, its territories, possessions, or commonwealths:

`I declare (or certify, verify, or state) under penalty of perjury that the foregoing is true and correct. Executed on (date). (Signature)'.

Record Source Categories:

From DoD personnel to include school registrars; personnel who manage the system to include DoD military and civilian personnel and contractors; faculty who are the facilitators and instructors for the courses, to include DoD military and civilian personnel and contractors. From training and personnel information systems; and health providers, individuals by interview and risk assessment surveys.

On September 16, 2011, Panhandle Eastern Pipe Line Company, LP (Panhandle) filed with the Federal Energy Regulatory Commission (Commission) an application under section 7(b) of the Natural Gas Act and the Rules and Regulations of the Commission's Regulations for authority to abandon the three remaining compressor units and appurtenant facilities at the Adams Compressor Station site in Texas County, Oklahoma. The abandonment would serve to align declining compression requirements of the gathering system feeding into the Adams Compressor Station. Furthermore, firm transportation services provided to existing Panhandle customers will not be affected, as more fully detailed in the Application.

Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit seven copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.fere.gov. Persons unable to file electronically should submit an original and seven copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE, Washington, DC 20426. This filing is accessible on-line at http://www.ferc.gov.using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail FERCOnlineSupport@ferc.gov, or call(866) 208-3676 (toll free). For TTY, call (202) 502-8659.

Take notice that on September 22, 2011, ANR Pipeline Company (ANR Pipeline), 717 Texas Street, Suite 2400, Houston, Texas 77002-2761, filed in Docket No. CP11-548-000, an application pursuant to Section 7(b) of the Natural Gas Act (NGA) and Part 157 of the Commission's regulations, requesting authorization to abandon its obligation to provide transportation service through approximately 26 miles of 16-inch diameter pipeline extending from an offshore production platform in Mississippi Canyon Block 194 connecting with approximately 14 miles of 18-inch diameter onshore pipeline to a point of connection with Southern Natural Gas Company's pipeline facilities in the Romere Pass Field, Plaquemines Parish, Louisiana, all as more fully set forth in the application which is on file with the Commission and open to public inspection. This filing may also be viewed on the Commission's Web site at http://www.ferc.gov using the “eLibrary” link. Enter the docket number, excluding the last three digits, in the docket number field to access the document. For assistance, call (866) 208-3676 or TTY, (202) 502-8659.

Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 14 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

Motions to intervene, protests and comments may be filed electronically via the internet in lieu of paper; see, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings.

The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, and service can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.